GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H11: THE DEVICE WAS RECEIVED FOR EVALUATION WITH THE RIGHT RING SEATED IN THE JAW ASSEMBLY. VISUAL INSPECTION OF THE RETURNED SAMPLE SHOWED SIGNS OF USE WERE VISIBLE SUCH AS DRIED BLOOD WHICH IS CONSISTENT WITH THE COMPLAINANT¿S STATEMENT. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLIES WERE 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. THERE WERE NO OBSERVED FUNCTIONAL MALFUNCTIONS WITH THE JAW ASSEMBLY, HOWEVER, VISUAL INSPECTION CONFIRMED THAT THE LEFT RING WAS DISLODGED FROM THE JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE RING OF A 3.0MM COUPLER FELL OFF. THIS WAS OBSERVED WHEN THE DEVICE WAS INSERTED FACE-DOWN INTO THE SURGICAL FIELD TO PERFORM AN ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.