FDA Adverse Event
Malfunction
Summary report: N
CONMED GOLDLINE 'A' ROCKER SWITCH PENCIL
MDR report key: 2152857
·
Received June 28, 2011
Report
- Report Number
- 1720159-2011-00034
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Report Date
- June 29, 2011
- Manufacturer
- CONMED ELECTROSURGERY
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CAUTERY PENCIL FROM THIS SPECIFIC INCIDENT WAS NOT RETURNED TO CONMED FOR EVALUATION. HOWEVER, THE FACILITY THAT REPORTED THIS EVENT ALSO REPORTED TWO OTHER EVENTS OF SIMILAR NATURE. THE DEVICES FROM ALL THREE INCIDENTS HAD IDENTICAL PRODUCT CATALOG NUMBERS AND LOT CODES. (B)(4).
Description of Event or Problem · 1
THE PENCIL HAD SOME SORT OF 'WHITE FILM', WHICH WAS ALMOST DUST-LIKE, WHICH CAUSED THE SWITCH ON THE PENCIL TO STICK AND STAY ACTIVATED AFTER THE BUTTON WAS RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED GOLDLINE 'A' ROCKER SWITCH PENCIL | ELECTROSURGICAL PENCIL, PRODUCT CODE: GEI | GEI | CONMED ELECTROSURGERY | NA | 1008275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |