MalfunctionMVR
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jun 25, 2026
Report 1416980-2026-02139 · MDR key 25630616
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
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT TWO (02) COUPLER,3.0MM WAS NOT CLOSING PROPERLY. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.