MalfunctionMVR
GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Feb 6, 2025 · Event occurred Dec 13, 2024
Report 21321706 · MDR key 21321706
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Synovis Micro Companies Alliance, IncModel number
GEM2754Catalog number
511100300060
Lot number
MS-35211-4464 USA
Patient
51 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FREE FLAP GRAFT, BILATERAL BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR FLAPS, BILATERAL MASTECTOMY WERE BEING PERFORMED ON THE PATIENT. DURING THE MICROVASCULAR PORTION OF THE FLAP SURGERY, THE GEM COUPLER, A MICROVASCULAR DEVICE, THAT IS TO CLAMP ONTO A VEIN WAS USED. THE FIRST COUPLER DID NOT CLAMP TIGHTLY ONTO THE VEIN SO A SECOND DEVICE (FROM THE SAME LOT #) WAS USED AND IT WORKED CORRECTLY.