FDA Adverse Event
Other
Summary report: N
SASCH COLD KNIFE
MDR report key: 359131
·
Received November 5, 2001
Report
- Report Number
- MW1023280
- Event Type
- Other
- Date Received
- November 5, 2001
- Date of Event
- November 1, 2001
- Report Date
- November 2, 2001
- Manufacturer
- KARL STORZ ENDOSCOPY AMERICA INC.
- Product Code
- EZO
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
COLD KNIFE BROKE OFF TWICE DURING UROLOGIC PROCEDURE. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49366 | SASCH COLD KNIFE | STRAIGHT COLD KNIFE | EZO | KARL STORZ ENDOSCOPY AMERICA INC. | 27068K | 23802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |