GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED A 3.5MM COUPLER PREMATURELY EJECTED FROM THE BLACK BUTTERFLY ASSEMBLY. A NEW 3.5MM COUPLER WAS LOADED ONTO THE ANASTOMOTIC COUPLER. THE PHYSICIAN INSERTED THE VESSEL SEND INTO THE COUPLER RINGS, EVERTED THE EDGES OVER THE PINS. AS THE PHYSICIAN WAS APPROXIMATING THE RINGS BY TURNING THE COUPLER INSTRUMENT KNOB, ONE OF THE RINGS PREMATURELY FELL/POPPED OUT OF THE BUTTERFLY ASSEMBLY. TO COMPLETE THE PROCEDURE THE PHYSICIAN CHOSE TO SUTURE THE VEIN ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE LOT NUMBER (10) AND SUBSEQUENT EXPIRATION DATE (17) ARE UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.