GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. THE 3.0MM COUPLER JAW ASSEMBLY HAD BOTH COUPLER RINGS STILL INTACT WHICH SHOWED SIGNS OF USE (DRIED BLOOD) WHICH IS CONSISTENT WITH THE ALLEGED EVENT TAKING PLACE DURING USE. THERE WAS NO VISIBLE DAMAGE TO THE JAW ASSEMBLY OR COUPLER RINGS THAT WOULD INDICATE THE DEVICE CONTRIBUTED TO THE ALLEGED EVENT. WHEN BROUGHT TOGETHER, THE PINS ON EACH COUPLER RING PROPERLY ALIGNED WITH THEIR MATING HOLE ON THE OPPOSING RING. THERE WAS NO INDICATION THAT THE RINGS WOULD NOT HAVE FUNCTIONED PROPERLY DURING THE SURGICAL PROCESS. THERE WAS NO TISSUE REMAINING ON THE COUPLER RINGS UPON RECEIPT FOR INVESTIGATION, THEREFORE, IT IS UNKNOWN IF THE AMOUNT OF TISSUE EVERTED ONTO THE PINS DURING THE SURGICAL PROCESS MAY HAVE CONTRIBUTED TO THE EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. 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.

Description of Event or Problem

IT WAS REPORTED THAT A 3.0MM COUPLER DID NOT CLOSE PROPERLY; FURTHER DESCRIBED AS "MISFIRE. COUPLER DID NOT MEET". THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.