GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Mar 21, 2025 · Event occurred Feb 20, 2025
Report 1416980-2025-01342 · MDR key 21663010
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2754Catalog number
511100300060
Lot number
SP24F18-2092120
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 D9, H3, H6, AND H11: H11: THE DEVICE WAS RECEIVED FOR EVALUATION. APPROXIMATING THE JAW ASSEMBLY USING AN ANASTOMOTIC INSTRUMENT WAS PERFORMED, AND NO DEFECTS WERE PRESENT. NO DEFECTS WERE VISIBLE IN THE RETURNED COUPLER RINGS. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
E1: INITIAL REPORTER POSTAL CODE: (B)(6). 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 3.0MM COUPLER FELL OUT OF THE DEVICE. THIS OCCURRED DURING ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.