GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D4 EXPIRATION AND UDI #, H4, H6, AND H11. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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 A BENT PIN AND "EJECTED FROM THE JAWS OF THE PLASTIC HOLDER". THIS OCCURRED DURING PRODUCT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6 AND H11. H11: THREE DEVICES WERE RECEIVED FOR EVALUATION ALONG WITH THREE COMPANION SAMPLES. THE USED 2.5 MM COUPLER JAW ASSEMBLIES WERE RETURNED IN A STERILIZED JAR WITH RINGS DISLODGED. ONE PAIR OF RINGS WERE FREE FLOATING IN THE JAR. UPON VISUAL INSPECTION OF THE USED 2.5 MM COUPLER, SIGNS OF USE WERE VISIBLE SUCH AS DRIED BLOOD AND TISSUE. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLIES WERE 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 RINGS WERE DISLODGED FROM THE JAW ASSEMBLY AND A BENT PIN WAS PRESENT. IT IS UNKNOWN IF ANY PORTION OF THE PREPARATION FOR USE OF THE COUPLER PRODUCT OR USE OF THE PRODUCT IN THE SURGICAL PROCESS MAY HAVE CONTRIBUTED TO THE ALLEGED DEFECT. THE REMAINING 2 JAW ASSEMBLIES USED IN THE REPORTED ALLEGED EVENT WERE RETURNED WITH BOTH RINGS DISLODGED, HOWEVER, THE RINGS FROM THOSE 2 JAW ASSEMBLIES WERE NOT RETURNED. THE THREE COMPANION SAMPLES (UNUSED SAMPLE FROM HOSPITAL INVENTORY OF THE SAME LOT NUMBER) OF THE 2.5 MM COUPLER PRODUCT FROM THE REPORTED ALLEGED EVENT WERE RETURNED FOR INVESTIGATION AS WELL. THE COMPANION SAMPLES WERE RECEIVED IN THEIR SPECIFIED PACKAGING, FULLY SEALED. UPON REVIEW OF THE RETURNED PRODUCTS, THE THREE COMPANION SAMPLES OF THE 2.5MM COUPLER JAW ASSEMBLIES WERE CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AND BROUGHT TOGETHER BY ROTATING THE AI KNOB TO MIMIC THE USE IN A SURGICAL PROCESS. THE RINGS ALIGNED AS INTENDED WHEN APPROXIMATED AND WERE ABLE TO BE PUSHED OUT OF THE JAWS UPON APPROXIMATION. THE COMPANION SAMPLES THAT WERE SENT FOR INVESTIGATION FUNCTIONED AS INTENDED. THE REPORTED CONDITION WAS VERIFIED. THE REPORTED CONDITION WAS NOT VERIFIED. HOWEVER, THE POTENTIAL THAT A BENT PIN MAY HAVE OCCURRED DURING PREPARATION FOR OR DURING USE WHEN EVERTING THE TISSUE ONTO THE PINS IN THE SURGICAL PROCESS. ADDITIONALLY, IF UNDUE PRESSURE WERE TO BE PLACED ON THE RING DURING THESE SAME TASKS, THERE IS POTENTIAL THAT THE RING MAY BECOME DISLODGED FROM THE JAW ASSEMBLY. THE EXACT ROOT CAUSE FOR THE SECOND AND THIRD ALLEGED 2.5 MM COUPLER NOT EJECTING FROM THE DELIVERY HOLDER IS ALSO UNKNOWN. THE RING RETENTION (THE FORCE REQUIRED TO EXPEL THE RINGS FROM THE JAW ASSEMBLY) RESULTS FOR THE LOT NUMBER PROVIDED WERE WITHIN SPECIFICATION. WHILE IT CANNOT BE COMPLETELY RULED OUT, IT IS UNLIKELY THAT THE MANUFACTURING OF THE PRODUCT CONTRIBUTED TO THE ALLEGATION THAT THE COUPLER. THE SUPPLIER OF THE COUPLER PRODUCT PERFORMS A PIN ALIGNMENT CHECK ON EACH JAW ASSEMBLY PRIOR TO PLACING IT IN THE WHITE PROTECTIVE HOLDER. THIS CHECK BRINGS THE TWO COUPLER RINGS TOGETHER TO ENSURE THEY WERE PLACED APPROPRIATELY IN THE JAW ASSEMBLY AND TO ALLOW THE SUPPLIER TO NOTE IF ANY DEFECTS WERE PRESENT IN THE JAW ASSEMBLY PRIOR TO SEALING IT INTO THE COUPLER TRAYS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.