GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Dec 17, 2025
Report 1416980-2025-06133 · MDR key 23833342
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Break
- Break
Patient
41 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED COUPLER BEING USED FOR AN ANASTOMOSIS FAILED (FURTHER DESCRIBED AS "COULD NOT GET IT TO WORK OR STOPPED WORKING"). THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
B3: EVENT DATE - THIS ISSUE OCCURRED ON AN UNSPECIFIED DATE IN AUGUST 2025. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: A5: ETHNICITY, B5, G4: PMA/510K # (UPDATE TO NI), H6 (UPDATE CODES), H10, H11. B5: THE DEVICE INVOLVED WAS AN UNSPECIFIED 3.0MM COUPLER. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.