Class I - Dangerous
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of the Americas
374 recalls • • Categories: Other Medical Devices, Infusion Pumps, Surgical Instruments, Diagnostic Equipment
Class I - Dangerous
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Class I - Dangerous
Potential for detachment of a distal tip component of the device during use.
Class I - Dangerous
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class I - Dangerous
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class I - Dangerous
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class I - Dangerous
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class I - Dangerous
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class I - Dangerous
Potential for detachment of a distal tip component of the device during use.
Class I - Dangerous
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Potential for rubber fragment detachment during use.
Potential for rubber fragment detachment during use.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Issue with software algorithm which may lead to overpressure events.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Issue with software algorithm which may lead to overpressure events.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Class I - Dangerous
Firm is initiating a removal due to continued reports of adverse events.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Devices which did not undergo thermoforming could deform and lose performance.
Class I - Dangerous
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Class I - Dangerous
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Potential for undetected, deformed a-traumatic tips.