GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jun 17, 2026 · Event occurred May 14, 2026
Report 1416980-2026-02063 · MDR key 25540381
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2753Catalog number
511100250060
Lot number
SP25F06-2291758
Product problems
- Failure to Align
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 PINS OF A GEM COUPLER,2.5MM FAILED TO MATCH AND ALIGNED AS EXPECTED, WHICH PREVENTED SUCCESSFUL ANASTOMOSIS DURING INTRA OPERATION. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.