GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE LOT NUMBER (10) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). E1: INITIAL REPORTER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A 3.5MM COUPLER WAS NOT ALIGNED DURING USE IN AN INTRA-OP PROCEDURE. THE ISSUE WAS FURTHER DESCRIBED AS, "THE SURGEON DEEMED IT BROKEN". A NEW COUPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 (EXPIRATION DATE, UDI), D9, H3, H4, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. THE 3.5MM COUPLER JAW ASSEMBLY HAD LEFT RING SEATED IN THE JAW ASSEMBLY. THE RIGHT RING WAS NOT INTACT IN THE JAW ASSEMBLY AND WAS RETURNED WITHIN THE ORIGINAL TRAY. THE JAW ASSEMBLY CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THE KNOB OF THE AI WAS THEN ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS IT WOULD IN A SURGICAL PROCESS. THERE WAS NO OBSERVED MALFUNCTION WITH THE JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.