FDA Adverse Event
Malfunction
Summary report: N
RF DENERVATION, 15 CM SPINE PROBE
MDR report key: 839861
·
Received February 27, 2007
Report
- Report Number
- 1216828-2007-00008
- Event Type
- Malfunction
- Date Received
- February 27, 2007
- Date of Event
- January 24, 2007
- Report Date
- February 23, 2007
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION
- Product Code
- MUK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
DURING RF PROCEDURE, AN ERROR 06 OCCURRED. THE CUSTOMER USED A BACK UP AND WORKED OK. THERE WAS A 45-MINUTE DELAY REPORTED IN THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF DENERVATION, 15 CM SPINE PROBE | PROBE, SPINE | MUK | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 7210272 | 376180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |