GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jun 19, 2026
Report 1416980-2026-02098 · MDR key 25565388
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
511190250060Catalog number
511190250060
Lot number
SP26B03-2408861
Product problems
- Failure to Align
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. DURING EVALUATION OF A PHOTO SAMPLE, TISSUE WAS OBSERVED TO BE EVERTED OVER THE PINS OF BOTH RINGS. THE RINGS APPEARED TO BE SUCCESSFULLY APPROXIMATED AND JOINED, ALTHOUGH THEY APPEARED TO BE SLIGHTLY MISALIGNED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.
Description of Event or Problem
DURING EVALUATION OF A PHOTO SAMPLE, IT WAS OBSERVED THAT A 2.5MM COUPLER HAD MISALIGNED RINGS. THE RINGS APPEARED TO BE SUCCESSFULLY APPROXIMATED AND JOINED, ALTHOUGH THEY APPEARED TO BE SLIGHTLY MISALIGNED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.