COUPLER
Received May 31, 2023 · Event occurred Apr 24, 2023
Report 1416980-2023-02621 · MDR key 17030497
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100150060
Lot number
SP20B171429604
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
Additional Manufacturer Narrative
B5: THIS EVENT WAS FURTHER DESCRIBED AS: ¿THE RING FELL OFF FROM THE DEVICE HOLDER UNEXPECTEDLY BEFORE ANASTOMOSIS.THE PROCESS STEP WAS INTRA-OP.¿ H10. THE DEVICE WAS RECEIVED FOR EVALUATION. THE 1.5MM JAW ASSEMBLY WITH ONE RING INTACT AND ONE RING NOT INTACT WERE RETURNED IN THE INNER TRAY FROM THE COUPLER PRODUCT. A VISUAL INSPECTION WAS PERFORMED WHICH REVEALED THE LEFT RING OF THE 1.5MM COUPLER WAS NO LONGER SEATED IN THE JAW ASSEMBLY WHICH INDICATED THAT THE RING HAD DISLODGED FROM THE JAW ASSEMBLY. 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.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE RING OF A 1.5MM COUPLER FELL OFF. THIS WAS IDENTIFIED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.