GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 (EXPIRATION DATE AND UDI), H4, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A VIDEO OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE VIDEO SHOWED AN ANASTOMOTIC PROCEDURE USING A 2.5 MM COUPLER DEVICE AND AN ANASTOMOTIC INSTRUMENT (AI). IT STARTS AFTER THE RINGS ARE JOINED BUT BEFORE EJECTION FROM THE JAW ASSEMBLY. A HEMOSTAT IS USED TO COMPRESS THE JAWS, THOUGH IT WAS UNCLEAR IF PROPER RING APPROXIMATION PER IFU WAS ACHIEVED AT THAT STAGE. THE AI IS THEN ACTUATED TO EJECT THE RINGS, WITH OBSERVED RESISTANCE LIKELY DUE TO TISSUE CAUGHT BETWEEN THE JAWS. AFTER EJECTION, THE HEMOSTAT IS AGAIN APPLIED, RESULTING IN A SLIGHT TIGHTENING OF THE RINGS. IT IS UNCLEAR WHETHER ANY GAP EXISTED BEFORE EJECTION. THE PROCEDURE ENDS WITH THE RINGS APPEARING TIGHTLY FITTED. 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 A 2.5MM COUPLER RING MAY OPEN OR FAIL TO MAINTAIN ITS PROPER CLOSURE DURING HANDLING, PREVENTING CORRECT COUPLING OF THE SYSTEM. THIS OCCURRED DURING SURGICAL PROCEDURES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

B3/D10: THE EVENTS OCCURRED BETWEEN JANUARY TO FEBRUARY 2026. E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.