GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Apr 14, 2026
Report 1416980-2026-01292 · MDR key 24875291
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2754Catalog number
511100300060
Lot number
SP25F03-2289121
Product problems
- Difficult to Open or Close
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A 3MM 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
ADDITIONAL INFORMATION: D4 (EXPIRATION DATE AND UDI), H4, 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 DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.