GEM MICROVASCULAR ANASTOMOTIC COUPLER
Received Mar 4, 2025
Report 1416980-2025-00937 · MDR key 21519002
Device
Generic name
Device,anastomotic,microvascular
Manufacturer
Baxter Healthcare CorporationModel number
GEM2754Catalog number
511100300060
Lot number
ASKU
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
51 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A 3.0MM COUPLER DID NOT CLAMP TIGHTLY ONTO THE VEIN. THIS WAS OBSERVED DURING A FREE FLAP GRAFT PROCEDURE. A NEW COUPLER WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
B3/D10: THE EVENT OCCURRED DURING AN UNSPECIFIED DATE OF DECEMBER 2024. D4 LOT #: THE REPORTED LOT WAS MS-35211-4464; HOWEVER, THIS IS NOT A VALID LOT FOR THIS PRODUCT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6, H11. 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.