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 THAT A COUPLER RING DETACHED. THE REPORTER STATED THAT THE RING FELL OFF AND COULD NOT BE USED. THIS OCCURRED DURING THE PREPARATION STAGE BEFORE SURGERY WHILE PREPARING TO ATTACH THE COUPLER TO THE MAIN UNIT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4, H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH SHOWED SIGNS OF USE (DRIED BLOOD AND TISSUE). 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

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, AND H6. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE 2.5MM COUPLER JAW ASSEMBLY WERE RETURNED WITH THE LEFT RING SEATED IN THE JAW ASSEMBLY. DURING VISUAL INSPECTION, 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 REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.