GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE EXPIRATION DATE IS NOT AVAILABLE FOR THIS PRODUCT; THEREFORE, THE EXPIRATION DATE PORTION OF THE UDI WAS NOT INCLUDED IN THE MDR SUBMISSION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT ONE SIDE OF A COUPLER CAME OFF. THIS OCCURRED WHILE PREPARING TO ATTACH THE COUPLER TO THE MAIN UNIT BEFORE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, AND H6. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE COUPLER PRODUCT WAS RETURNED IN A PETRI DISH WITH ONLY THE RINGS PRESENT. DURING INVESTIGATION SIGNS OF USE (DRIED BLOOD AND TISSUE) WERE VISIBLE. THIS IS CONSISTENT WITH THE REPORTED ALLEGED EVENT OCCURRING DURING THE SURGICAL PROCESS. THE RINGS WERE NO LONGER SEATED IN THE JAW ASSEMBLY. NO DEFECTS WERE VISIBLE ON THE RETURNED RINGS. VISUAL INSPECTION OF THE RETURNED COMPONENTS SHOWED NO DEFECT THAT WOULD LEAD TO THE ALLEGED EVENT BEING RELATED TO THE MANUFACTURING OF PRODUCT. A DEFINITIVE ROOT CAUSE FOR HOW THE RING DISLODGED FROM THE JAW ASSEMBLY COULD NOT BE DETERMINED. 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THERE WERE SIGNS OF USE (DRIED BLOOD AND TISSUE) WHICH ARE CONSISTENT WITH THE ALLEGED EVENT OCCURRING DURING THE SURGICAL PROCESS. WHILE SIGNS OF USE ARE VISIBLE, OTHER VISUAL INVESTIGATION INTO THE ALLEGED EVENT COULD NOT BE COMPLETED AS THE PHOTO PROVIDED DOES NOT OFFER ADEQUATE DETAILS OR EVIDENCE TO CONCLUDE A DEFINITIVE ROOT CAUSE. 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.