FDA Adverse Event
Malfunction
Summary report: N
SINGLE USE 3-LUMEN SPHINCTEROTOME V
MDR report key: 16138258
·
Received January 11, 2023
Report
- Report Number
- 16138258
- Event Type
- Malfunction
- Date Received
- January 11, 2023
- Date of Event
- November 25, 2022
- Report Date
- December 1, 2022
- Manufacturer
- GYRUS ACMI INC.
- Product Code
- NLR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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 · 0
WHEN ATTEMPTING TO USE THE SPHINCTEROTOME THE WIRE ON THE END WAS NOTED TO BE BROKE. THE EQUIPMENT WAS REMOVED CAREFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1179066 | SINGLE USE 3-LUMEN SPHINCTEROTOME V | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | NLR | GYRUS ACMI INC. | 27V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26280 DA | Female |