GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Feb 6, 2026
Report 1416980-2026-00499 · MDR key 24284503
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2755Catalog number
512100350060
Lot number
SP24H05-2117075
Product problems
- Difficult to Open or Close
- Device Dislodged or Dislocated
Patient
NA · Unknown
- 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 A 3.5MM FLOW COUPLER DID NOT CLOSE PROPERLY AND WAS MISALIGNED. THE ISSUE OCCURRED DURING AN INTRA-OPERATION STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.