MalfunctionMVR
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jun 10, 2026 · Event occurred Apr 7, 2026
Report 25456855 · MDR key 25456855
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Synovis Micro Companies Alliance, IncCatalog number
GEM2754
Lot number
SP26A282405823
Patient
56 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COUPLER WAS PLACED ON THE RIGHT BREAST. AS SURGICAL TEAM WAS CONNECTING THE TWO PIECES OF THE COUPLER, COUPLER MALFUNCTIONED AND PRONGS DID NOT ALIGHT WITH EACH OTHER. BECAUSE OF THIS, ANASTOMOSIS BETWEEN VESSELS WERE NOT COMPLETED AND ANOTHER COUPLER DEVICE WAS NEEDED TO ACHIEVE AN ANASTOMOSIS.