MalfunctionMVR
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received May 28, 2026 · Event occurred Apr 27, 2026
Report 1416980-2026-01796 · MDR key 25317324
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2751Catalog number
511100150060
Lot number
ASKU
Product problems
- Fitting Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RING OF THREE (3) 1.5MM GEM COUPLERS DID NOT FIT. THIS OCCURRED DURING USE IN THE OPERATING ROOM. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
THE DEVICES WERE DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.