FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 2591238
·
Received May 24, 2012
Report
- Report Number
- 2134070-2012-00074
- Event Type
- Malfunction
- Date Received
- May 24, 2012
- Report Date
- August 12, 2011
- Manufacturer
- STERILMED, INC.
- Product Code
- NLW
- PMA / PMN Number
- K012685
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FINAL INVESTIGATION SHOWED THAT THE LOOP OF THE DEVICE WAS BROKEN, AND THERE WERE BURNED AREAS ON THE LOOP AND SHEATHING. IT APPEARED THAT A PIECE OF THE ELECTRODE LOOP WAS MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ENDOSCOPIC ELECTRODE HAD AN IMPROPER ANGLE TO IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | ENDOSCOPIC ELECTRODE (NLW) | NLW | STERILMED, INC. | 27040G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |