Surgical Instruments

It has been found that potential unintended laser activation can occur without foot pedal depression.

Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.

Non-sterile product labeled as sterile was distributed.

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Reports were received the elastomer cup material is crumbling.

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Demonstrated recognition and compatibility issues with syringe infusion pumps.