GEM Microvascular Anastomotic COUPLER
Received Jul 29, 2026 · Event occurred Jun 10, 2026
Report 1416980-2026-02485 · MDR key 50075717
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2755Catalog number
512100350060
Lot number
SP25E01-2271123
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the rings of two (2) GEM COUPLERs,3.5MM were detached. This occurred during the placement of the coupler device on the anastomotic instrument. The device was replaced to resolve the issue. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Additional Manufacturer Narrative
E1: Initial Reporter Address: (b)(6) Should additional relevant information become available, a supplemental report will be submitted.