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 THE RIGHT-SIDE RING OF THREE (3) 2.0MM COUPLERS FELL OFF. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 EXPIRATION AND UDI#, D9, H3, H4, H6 (UPDATE CODES), H11. CORRECTION: B5 AND D4 (MODEL #, CATALOGUE #, AND DI PORTION OF UDI #). B5: UPDATE "2.0MM" TO "2.5MM". H11: THREE (3) DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH SHOWED SIGNS OF USE AND THE RIGHT RING WAS OBSERVED TO BE DISLODGED FROM EACH JAW ASSEMBLY. DURING THE FUNCTIONAL TESTING, THE JAW ASSEMBLIES WERE CLICKED INTO AN IN-LAB ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THERE WERE NO OBSERVED FUNCTIONAL ISSUES WITH THE JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE 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.