COUPLER
Received Feb 23, 2023
Report 1416980-2023-00638 · MDR key 16427581
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100300060
Lot number
SP22B021621437
Product problems
- Disconnection
- Disconnection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H10: THE DEVICE WAS RECEIVED FOR EVALUATION. THE COUPLER RINGS AND THE JAW ASSEMBLY WERE RETURNED, FREE FLOATING, IN THE INNER COUPLER TRAY. VISUAL INSPECTION REVEALED SLIGHT DAMAGE TO THE COUPLER RING THAT IS CONSISTENT WITH THE COUPLER RING BEING MANIPULATED WITH A MICROSURGICAL INSTRUMENT. A SLIGHT MISALIGNMENT WAS VISIBLE TO THE APPROXIMATED RINGS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A 3.0MM COUPLER CAME OFF AT THE CARTRIDGE. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.