MalfunctionNLR
SINGLE USE 3-LUMEN SPHINCTEROTOME V
Received Jan 11, 2023 · Event occurred Nov 25, 2022
Report 16138258 · MDR key 16138258
Device
Generic name
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Manufacturer
Gyrus Acmi Inc.Catalog number
KD-V411M-0720
Lot number
27V
Product problems
- Break
Patient
26280 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHEN ATTEMPTING TO USE THE SPHINCTEROTOME THE WIRE ON THE END WAS NOTED TO BE BROKE. THE EQUIPMENT WAS REMOVED CAREFULLY.
Description of Event or Problem
WHEN ATTEMPTING TO USE THE SPHINCTEROTOME THE WIRE ON THE END WAS NOTED TO BE BROKE. THE EQUIPMENT WAS REMOVED CAREFULLY.