GEM FLOW COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6, H11 H11: TWO (2) ACTUAL DEVICES WERE RECEIVED FOR EVALUATION. THE RETURNED PRODUCT FROM THE REPORTED ALLEGED EVENT SHOWED SIGNS OF USE (DRIED BLOOD/TISSUE) WHICH IS CONSISTENT WITH THE ALLEGED EVENTS OCCURRING DURING USE. THE FIRST RETURNED 2.5MM FLOW COUPLER PRODUCT REVIEWED HAD ONE RING THAT WAS NO LONGER SEATED IN THE LEFT SIDE OF THE JAW ASSEMBLY WHILE THE SECOND RETURNED 2.5MM FLOW COUPLER PRODUCT REVIEWED HAD ONE RING THAT WAS NO LONGER SEATED IN THE RIGHT JAW OF THE JAW ASSEMBLY. THE REMAINING RING IN BOTH ASSEMBLIES WAS INTACT IN ITS RESPECTIVE JAW. BOTH OF THE DISLODGED RINGS (ONE FROM EACH JAW ASSEMBLY) HAD DRIED BLOOD AND TISSUE PRESENT INDICATING EVERSION OF THE TISSUE ONTO THE PINS HAD OCCURRED DURING THE SURGICAL PROCESS PRIOR TO THE RINGS BECOMING DISLODGED FROM THE JAW ASSEMBLY. DURING RETURNED PRODUCT REVIEW, THERE WAS NO OBSERVED DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE ALLEGED DEFECTS. THIS COMPLAINT WILL BE CONFIRMED AS BOTH 2.5MM FLOW COUPLER PRODUCTS WERE RETURNED WITH A DISLODGED RING FROM THE JAW ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION 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.

Description of Event or Problem

IT WAS REPORTED THAT THE RINGS OF TWO (2) 2.5MM FLOWCOUPLERS PREMATURELY EJECTED (FELL OFF) FROM THE CLIP. THIS WAS OBSERVED BEFORE CLOSING THE APPLICATOR, WHEN THE RING WAS PLACED IN THE VEIN. DURING THE PROCEDURE, THE RING FELL OUT OF THE CLIP WHILE SECURING THE VEIN. THE SURGEON WAS UNABLE TO LOCATE THE RING WITHIN THE CLIP. AS A RESULT, A SECOND IMPLANT WAS UTILIZED. THE SAME CHECKS WERE PERFORMED, AND PROCEEDED WITH EXTRA CARE; HOWEVER, THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.