COUPLER
Received Dec 29, 2023 · Event occurred Nov 24, 2023
Report 1416980-2023-06816 · MDR key 18419489
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100300060
Lot number
SP22J24-1758140
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- 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 RING FELL OFF FROM THE DEVICE HOLDER BEFORE ANASTOMOSIS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
H10: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OBSERVED THAT THE RINGS APPEARED TO BE APPROPRIATELY ALIGNED; WHICH WOULD BE DIFFICULT TO PERFORM HAD THE RING BEEN DISLODGED FROM THE JAW ASSEMBLY. A REVIEW OF THE JAW ASSEMBLY SHOWED NO VISIBLE DAMAGE. THE JAW ASSEMBLY CLICKED INTO THE ANASTOMOTIC INSTRUMENT AS INTENDED. THE KNOB OF THE AI WAS THEN ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS IT WOULD IN A SURGICAL PROCESS. THERE WAS NO OBSERVED FUNCTIONAL MALFUNCTION WITH THE JAW ASSEMBLY. THE REPORTED CONDITION WAS NOT VERIFIED. 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.