GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Aug 12, 2024 · Event occurred Jul 15, 2024
Report 1416980-2024-04191 · MDR key 19960638
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Synovis Micro Companies Alliance, IncModel number
GEM2754Catalog number
511100300060
Lot number
NI
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PLASTIC RING OF TWO (2) 3.0MM COUPLERS CAME LOOSE FROM THE DEVICE. THE RINGS WHERE THE VEIN ATTACHES CAME LOOSE DURING FREE FLAP PROCEDURE PRIOR TO THE SURGEON READINESS. A THIRD 3.0MM COUPLER WITH A DIFFERENT LOT NUMBER WAS THEN OPENED AND USED WITH NO ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.