FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS SNARE MASTER
MDR report key: 2150748
·
Received June 29, 2011
Report
- Report Number
- MW5021228
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 29, 2011
- Manufacturer
- OLYMPUS
- Product Code
- FDI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT UNDERGOING A COLONOSCOPY AND POLYPECTOMY. DISPOSABLE ELECTROSURGICAL SNARE DID NOT DELIVER CURRENT TO THE SITE AND DID NOT CUT THROUGH THE POLYP. IT WAS REMOVED AND PROCEDURE COMPLETED WITH ANOTHER DEVICE. NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS SNARE MASTER | SNARE | FDI | OLYMPUS | SD-2300-20 | 12K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |