GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Dec 31, 2025 · Event occurred Nov 25, 2025
Report 1416980-2025-06262 · MDR key 23936428
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2755Catalog number
512100350060
Lot number
SP24H05-2117075
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE RINGS OF A 3.5MM COUPLER REPEATEDLY DISLODGED FROM THE INSTRUMENT PRIOR TO PERFORMING THE ANASTOMOSIS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
CORRECTION TO F10/H6: COMPONENT CODES: UPDATE THE CODE "G04034" TO "G04111". ADDITIONAL INFORMATION: H4, H6(UPDATE CODES), 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.