GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Aug 26, 2024 · Event occurred Jul 26, 2024
Report 1416980-2024-04491 · MDR key 20064863
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Synovis Micro Companies Alliance, IncModel number
GEM2755Catalog number
512100350060
Lot number
SP23C07-180727
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
ADDITIONAL INFORMATION WAS ADDED TO H6, AND H11: 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.
Description of Event or Problem
IT WAS REPORTED THAT THE RING OF A 3.5MM COUPLER PREMATURELY EJECTED (FELL OFF) FROM THE BLACK BUTTERFLY ASSEMBLY. THIS WAS OBSERVED AFTER THE COUPLER WAS LOADED ONTO THE ANASTOMOTIC DEVICE AND LAID ON THE STAND. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.