GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

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

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 VESSELS END INTO THE COUPLER RINGS AND 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. THE RINGS WERE REMOVED BY CUTTING THE VESSEL ENDS. THE PHYSICIAN STARTED OVER WITH A NEW SET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.