GEM FLOW COUPLER

Description of Event or Problem

IT WAS REPORTED THAT A 2.5MM FLOWCOUPLER SPRUNG OPEN AND FAILED TO LOCK INTO PLACE WHEN ATTEMPTING TO CLOSE THE IMPLANTABLE DEVICE. THIS WAS OBSERVED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4: UNIQUE IDENTIFIER (UDI), D9, H3, H4, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. THE 2.5MM COUPLER JAW ASSEMBLY HAD BOTH COUPLER RINGS INTACT. 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 ALIGNED APPROPRIATELY. THERE WAS NO INDICATION THAT THE RINGS WOULD NOT HAVE FUNCTIONED PROPERLY DURING THE SURGICAL PROCESS. 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.