GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THREE (3) 2.5MM COUPLERS DID NOT FUNCTION PROPERLY. FOR TWO (2) COUPLERS, THE ANASTOMOSIS RING COULD NOT BE PUSHED OUT SMOOTHLY AND THE BASE SHATTERED AFTER WITHDRAWAL. FOR ANOTHER COUPLER, THE ANASTOMOSIS RING COULD NOT BE CLOSED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H11: A PORTION OF (1) ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED A JAW ASSEMBLY WITH TWO BROKEN JAWS RETURNED IN THE INNER AND OUTER TRAY; NEITHER OF THE COUPLER RINGS WERE RETURNED FOR EVALUATION. THERE WERE MARKS VISIBLE ON THE JAW ASSEMBLY PORTIONS THAT WERE INCONSISTENT WITH THE USE OF AN ANASTOMOTIC INSTRUMENT; THE INSTRUMENT WOULD BE USED DURING THE SURGICAL PROCESS TO BRING THE RINGS TOGETHER TO BEGIN THE APPROXIMATION OF THE RINGS DURING THE ANASTOMOSIS. THE BROKEN JAW ASSEMBLY WAS VERIFIED. THE CAUSE OF THE BROKEN COMPONENT COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.