GEM MICROVASCULAR ANASTOMOTIC COUPLER

Description of Event or Problem

IT WAS REPORTED THAT A COUPLER HAD MISALIGNED RINGS. THIS WAS IDENTIFIED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION. THE JAW ASSEMBLY WAS RETURNED WITH BOTH RINGS SEATED. DURING VISUAL INSPECTION THERE WERE SIGNS OF USE SUCH AS DRIED BLOOD ON THE RING, INDICATING THE DEVICE HAD BEE USED. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLY WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THE KNOB OF THE AI WAS ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED WITHIN THE SURGICAL PROCESS. THE RINGS HAD ALIGNED AND MET THE APPROPRIATE MATING HOLES. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.