FDA Adverse Event
Injury
Summary report: N
RF DENERVATION PROBE
MDR report key: 1062896
·
Received June 19, 2008
Report
- Report Number
- 1020279-2008-00182
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 6, 2008
- Manufacturer
- SMITH & NEPHEW, INC./ORTHOPAEDIC DIV.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PROBE EXPERIENCED A "WARNING O6" ERROR MESSAGE DURING A PROCEDURE. THE PROCEDURE WAS PAUSED UNTIL A BACK UP DEVICE WAS AVAILABLE. SURGERY TIME WAS EXTENDED FOR 2 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF DENERVATION PROBE | RF DENERVATION PROBE | GEI | SMITH & NEPHEW, INC./ORTHOPAEDIC DIV. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |