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 2.5MM COUPLER HAD DEFECTS. THIS WAS OBSERVED DURING INTRAOPERATIVE STAGE. THE ISSUE WAS DESCRIBED AS "PINS WERE LOOSE IN THE COUPLER". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6 H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. THE COMPANION SAMPLE WAS RECEIVED IN ITS SPECIFIC PACKAGING, FULLY SEALED. THE IMPLICATED SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. UPON REVIEW OF THE RETURNED COMPANION SAMPLE, THE 2.5MM COUPLER WAS CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AND BROUGHT TOGETHER. THIS WAS TO MIMIC THE USE IN THE SURGICAL PROCESS. THE RINGS ALIGNED WHEN APPROXIMATED. THERE WERE NO ¿LOOSE PINS¿ FOUND ON THE RINGS OF THE COUPLER JAW ASSEMBLY. THE SAMPLE THAT WAS SENT IN FOR INVESTIGATION MET ALL IN-PROCESS AND FINISHED PRODUCT RELEASE SPECIFICATION. THE DEVICE HAD FUNCTIONED AS INTENDED. THE REPORTED CONDITION WAS NOT VERIFIED FOR THE COMPANION SAMPLE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.