FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 105880
·
Received July 16, 1997
Report
- Report Number
- MW1011698
- Event Type
- Malfunction
- Date Received
- July 16, 1997
- Date of Event
- May 22, 1997
- Report Date
- July 7, 1997
- Manufacturer
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Product Code
- FFZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
POWER CORD (CABLE) POPPED AND FLASHED, THEN SPLIT IN HALF AT THE JUNCTURE TO PLASTIC CONNECTOR. NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | RESECTOSCOPE ELECTRODE CABLE | FFZ | KARL STORZ ENDOSCOPY-AMERICA, INC. | #279 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |