FDA Adverse Event
Malfunction
Summary report: N
SINGLE NEEDLE ENDO-CAUTERY
MDR report key: 17416
·
Received November 3, 1994
Report
- Report Number
- MW1003895
- Event Type
- Malfunction
- Date Received
- November 3, 1994
- Date of Event
- October 31, 1994
- Report Date
- November 2, 1994
- Manufacturer
- ELMED, INC.
- Product Code
- KNS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING USE, THE TIP OF THE PROBE CAME OFF. IT WAS VISUALIZED ON X-RAY BUT COULD NOT BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGLE NEEDLE ENDO-CAUTERY | KNS | ELMED, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |