MalfunctionMVR
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jun 26, 2026 · Event occurred May 5, 2026
Report 1416980-2026-02154 · MDR key 25640094
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2754 ICatalog number
511100300010
Lot number
SP26B20-2418869
Product problems
- Failure to Align
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A COUPLER,3.0MM MALFUNCTIONED AND FAILED TO COUPLE AS INTENDED. THIS OCCURRED DURING AN INTRA OPERATION PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.