GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jul 22, 2025 · Event occurred Jun 17, 2025
Report 1416980-2025-03847 · MDR key 22566300
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2756Catalog number
512100350060
Lot number
SP24I16-2139362
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4 (CATALOGUE, EXPIRATION DATE AND UDI), H6 (UPDATE CODES), 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
D4: UNIQUE IDENTIFIER (UDI) #: THE MANUFACTURING DATE (11) IS NOT KNOWN AT THIS TIME AND WILL BE REASSESSED AFTER DEVICE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A 4.0MM COUPLER FALLEN OUT OF THE WINGED ASSEMBLY. THIS WAS OBSERVED DURING AN INTRA-OP PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.