FDA Adverse Event
Other
Summary report: N
K-STORZ
MDR report key: 249417
·
Received November 10, 1999
Report
- Report Number
- MW1017519
- Event Type
- Other
- Date Received
- November 10, 1999
- Date of Event
- October 21, 1999
- Manufacturer
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Product Code
- KNS
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHILE PERFORMING A TRANSURETHRAL RESECTION OF A BLADDER NECK STRICTURE, THE COLD KNIFE BROKE OFF 1/2 WAY DOWN THE SHAFT AFTER THE PHYSICIAN BEGAN TO CUT TISSUE. THE BROKEN END WAS RETRIEVED FROM THE PT'S BLADDER WITHOUT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-STORZ | DISPOSABLE COLD KNIFE | KNS | KARL STORZ ENDOSCOPY-AMERICA, INC. | * | FL 02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |