GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jul 10, 2026
Report 1416980-2026-02286 · MDR key 25778764
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2754Catalog number
511100300060
Lot number
SP26A282405823
Product problems
- Misconnection
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3/D10: THE ISSUE OCCURRED ON AN UNSPECIFIED DATE IN APRIL 2026. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT PINS OF A GEM MICROVASCULAR ANASTOMOTIC COUPLER,3.0MM DID NOT ALIGN WITH EACH OTHER. THIS OCCURRED DURING BREAST RECONSTRUCTION WITH DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) FLAP, IN THE OPERATION THEATRE. 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.