MalfunctionMVR
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jun 25, 2026 · Event occurred Apr 8, 2026
Report 1416980-2026-02131 · MDR key 25617788
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2753Catalog number
511100250060
Lot number
SP25E02-2271667
Product problems
- Disconnection
- Detachment of Device or Device Component
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,2.5MM DETACHED WHEN ATTEMPTING TO ATTACH A BLOOD VESSEL TO IT. THIS OCCURRED DURING A FREE FLAP SURGERY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.