COUPLER
Received Aug 18, 2023 · Event occurred Jul 20, 2023
Report 1416980-2023-04174 · MDR key 17573908
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100250060
Lot number
ASKU
Product problems
- Unintended Movement
- Unintended Movement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H10: A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PINS OF TWO (2) 2.5MM COUPLERS WERE NOT ALIGNED. THIS WAS IDENTIFIED AFTER DEPLOYMENT OF THE COUPLERS DURING AN INTRAOPERATIVE PROCEDURE. THIS EVENT WAS FURTHER DESCRIBED AS RIGHT SIDE, THEN LEFT SIDE "MISFIRED". NEW COUPLERS WERE USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.