GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Jan 30, 2026
Report 1416980-2026-00418 · MDR key 24225356
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2754Catalog number
511100300060
Lot number
NI
Product problems
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE NO.:(B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND LOOSE RINGS WITHIN THE INNER TRAY WERE OBSERVED. FUCNTIONAL TESTING WAS PERFORMED, AND NO MALFUNCTIONS WERE OBSERVED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
DURING EVALUATION OF A RETURNED 3.0MM COUPLER, LOOSE RINGS WITHIN THE INNER TRAY WERE OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE.