GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6, H11. 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT A 2.0MM COUPLER HAD A BENT PIN; FURTHER DESCRIBED AS "ONE OF THE PRONGS WAS BENT". THIS WAS OBSERVED DURING INSPECTION, BEFORE USE IN A BILATERAL BREAST DIEP FLAP RECONSTRUCTION PROCEDURE. A NEW COUPLER WAS USED TO CONTINUE WITH THE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.