GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE RINGS OF A 1.5MM COUPLER OPENED A FEW SECONDS AFTER BEING EJECTED BY THE COUPLER APPLICATOR DURING A PATIENT SURGERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

CORRECTION B5. ADDITIONAL INFORMATION: D9, H6 AND H11. B5: CORRECTION TO THE PREVIOUS B5: THIS EVENT REQUIRED THE SURGEON TO "CUT THE VEIN ON TWO OCCASIONS AND FINALLY SUTURE IN THE TRADITIONAL WAY." THIS DESCRIPTION INDICATES THAT THE EVENT CAUSED THE REQUIREMENT FOR FURTHER SURGICAL INTERVENTION; NONETHELESS, A DEGREE OF VESSEL TRIMMING/MANIPULATION IS EXPECTED DURING SUCH PROCEDURES. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE 1.5 MM JAW ASSEMBLY WAS RETURNED IN A COUPLER TRAY WITH ONLY THE JAW ASSEMBLY WITH RINGS INTACT. DURING VISUAL INSPECTION, THE RETURNED COMPONENTS SHOW NO SIGNS OF USE (DRIED BLOOD OR TISSUE). THIS IS NOT CONSISTENT WITH THE COMPLAINT¿S STATEMENT THAT THE ALLEGED EVENT HAPPENED DURING USE, AFTER THE RINGS WERE EJECTED FROM THE JAW ASSEMBLY. DURING FUNCTIONAL EVALUATION, THE JAW ASSEMBLY CLICKED INTO THE ANASTOMOTIC INSTRUMENT AS WOULD BE DONE DURING THE SURGICAL PROCESS. THE KNOB WAS ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED WITHIN THE SURGICAL PROCESS. THERE WERE NO OBSERVED MALFUNCTIONS WITH THE JAW ASSEMBLY. WHEN THE JAW ASSEMBLY WAS BROUGHT TOGETHER THE RINGS ALIGNED; HOWEVER, PRIOR TO APPROXIMATION, THE RING WAS NOT SEATED PROPERLY IN THE LEFT JAW. 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 CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, AS THE EVENT DESCRIPTION NOTED, THE RINGS HAD BEEN EJECTED WHILE THE RETURNED 1.5 MM RETURNED COUPLER PRODUCT HAD BOTH RINGS INTACT IN THE JAW ASSEMBLY. WHILE IT CANNOT BE COMPLETELY RULED OUT, IT IS UNLIKELY THAT THE MANUFACTURING OF THE PRODUCT CONTRIBUTED TO THE ALLEGATIONS AS NO DEFECT COULD BE FOUND WITH THE RETURNED 1.5 MM COUPLER PRODUCT. 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO B1, B2, B5, H1, AND H6. ADDITIONAL INFORMATION WAS ADDED TO B5: IT WAS REPORTED THAT THE RINGS OF A 1.5MM COUPLER OPENED A FEW SECONDS AFTER BEING EJECTED BY THE COUPLER APPLICATOR DURING PATIENT SURGERY. THE SURGEON WAS REQUIRED TO TRIM THE VEIN AND USE STANDARD METHODS OF SURGICAL TECHNIQUE (SUTURING). THERE WERE NO SYMPTOMS PRESENTED BY THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. H11: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.