GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

CORRECTION TO D4 (MODEL, CATALOGUE, UDI). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4: EXPIRATION DATE AND UDI, D9, H3, H4, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL INSPECTION NOTED A MISALIGNMENT OF THE ADJOINED RINGS, AND NO ADDITIONAL RING OR PIN DEFORMITIES WERE IDENTIFIED. BASED ON THE RELIEF FEATURES ON THE RING, THE MISALIGNMENT APPEARED TO BE ALIGNED WITH THE DIRECTION OF INSERTION INTO THE JAW ASSEMBLY. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLY WAS INSERTED INTO THE ANASTOMOTIC INSTRUMENT (AI) WITH AN AUDIBLE CLICK, AND ACTUATION OF THE DEVICE APPROXIMATED THE JAW ARMS AS EXPECTED. FOLLOWING THE COMPLETE APPROXIMATION OF THE JAW ARMS, A SLIGHT VERTICAL OFFSET BETWEEN THE TWO JAW ARMS WAS OBSERVED. ADDITIONALLY, DRIED TISSUE WAS OBSERVED ON THE TORSION SPRING, ALONG WITH A SLIGHT GAP BETWEEN THE TOP TWO COILS ON THE RIGHT SIDE. THE REPORTED CONDITION WAS VERIFIED; HOWEVER, 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 PINS OF A COUPLER 1.5MM FAILED TO MATCH AND ALIGNED AS EXPECTED, WHICH PREVENTED SUCCESSFUL ANASTOMOSIS. THIS OCCURRED DURING INTRA OPERATIVE STAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. 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). E1: INITIAL REPORTER PHONE NO.: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.