Potential esophageal laceration during a patient procedure
US Endoscopy Group
10 recalls • • Categories: Diagnostic Equipment, Other Medical Devices, Surgical Instruments
Class I - Dangerous
The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
The company has determined the sterility cannot be assured for the affected lot.
The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.
Class I - Dangerous
A wire component on the distal grasping assembly of the device became detached..
Packaging non-conformance related to the integrity of the sterile pouch seal.
The firm was notified by their customers that there was a water leakage from the white tubing connector.
When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.