GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE ANASTOMOSIS RINGS OF TWO (2) 1.0MM COUPLERS DETACHED. THE ISSUE WAS FURTHER DESCRIBED AS, "COULD NOT ACHIEVE PROPER ANASTOMOSIS". THIS OCCURRED PRIOR TO PATIENT USE. TO RESOLVE THE EVENT, THE SURGEON PERFORMED THE ANASTOMOSIS MANUALLY. THERE WAS NO PATIENT INVOLVEMENT. 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 DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.