MalfunctionGEE
REUSABLE MARKED SPRING TIP GUIDEWIRE
Received Oct 29, 2020 · Event occurred Oct 15, 2020
Report 10754814 · MDR key 10754814
Device
Generic name
Brush, Biopsy, General & Plastic Surgery
Manufacturer
Conmed CorporationModel number
000150Catalog number
000150
Product problems
- Break
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE REUSABLE SPRING TIP GUIDEWIRE WAS REQUESTED BY THE PHYSICIAN FOR THE PROCEDURE. THE SURGICAL TECHNICIAN EXAMINED THE GUIDEWIRE AND ALSO TESTED THE END FOR INTEGRITY. THE PHYSICIAN ALSO TESTED THE GUIDEWIRE AND THE WIRE/COIL FLEXIBLE END BROKE OFF PRIOR TO USE IN THE PATIENT. THIS IS THE SECOND REUSABLE SPRING TIP GUIDEWIRE ISSUE IN RECENT MONTHS. THE MANUFACTURER DOES NOT HAVE GUIDELINES ON HOW LONG THE GUIDEWIRES LAST AND WHEN TO PULL OUT OF SERVICE.