FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 2591243
·
Received May 24, 2012
Report
- Report Number
- 2134070-2012-00060
- Event Type
- Malfunction
- Date Received
- May 24, 2012
- Report Date
- March 10, 2011
- Manufacturer
- STERILMED, INC.
- Product Code
- NLW
- PMA / PMN Number
- K012685
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL INVESTIGATION SHOWED THAT THE DEVICE WAS DAMAGED. THE INSULATION ON THE DISTAL TIP WAS BURNT AND MELTED, AND THE DEVICE WAS ALSO BENT AT A NOTICEABLE ANGLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE BEING USED DURING A PROCEDURE, AN ENDOSCOPIC ELECTRODE ARCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | ENDOSCOPIC ELECTRODE (NLW) | NLW | STERILMED, INC. | 27050G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |