GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER PHONE NO.: 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 2.5MM COUPLER BECAME DISLODGED FROM THE INSTRUMENT. THIS WAS OBSERVED AFTER ASSEMBLY OF THE COUPLING SYSTEM AND PRIOR TO PERFORMING THE ANASTOMOSIS. THE RINGS WERE THEN SAFELY REMOVED, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW, IDENTICAL DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH SHOWED SIGNS OF USE AND THE LEFT RING DISLODGED FROM THE JAW ASSEMBLY. 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. 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 CONDITION WAS NOT 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.