FDA Adverse Event
Malfunction
Summary report: N
KARL STORZ
MDR report key: 462182
·
Received May 23, 2003
Report
- Report Number
- MW1028494
- Event Type
- Malfunction
- Date Received
- May 23, 2003
- Date of Event
- February 19, 2003
- Report Date
- May 5, 2003
- Manufacturer
- KARL STORZ
- Product Code
- FBJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING RESECTIONING OF THE PROSTATE, THE STORZ CAUTERY CORD EXPLODED AND GAVE A FLASH OF ELECTRICAL CHARGE. THE CORD CUT ITSELF IN HALF. NO INJURY INCURRED BY PT OR DR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | HIGH FREQUENCY CORD | FBJ | KARL STORZ | 277KB | LK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |