FDA Adverse Event
Malfunction
Summary report: N
ABC PROBE
MDR report key: 1103544
·
Received August 8, 2008
Report
- Report Number
- MW5007940
- Event Type
- Malfunction
- Date Received
- August 8, 2008
- Date of Event
- July 3, 2008
- Report Date
- August 1, 2008
- Manufacturer
- CONMED
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE USING PROBE DURING LIVER BIOPSY THE MD SMELLED SOMETHING BURNING. PROBE TAKEN OUT OF PT AND INSPECTED. END FOUND BURNED. NO KNOWN PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABC PROBE | NONE | GEI | CONMED | 160656 | 0506 171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |