FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 2410817
·
Received January 6, 2012
Report
- Report Number
- 9610617-2012-00001
- Event Type
- Other
- Date Received
- January 6, 2012
- Date of Event
- December 4, 2011
- Report Date
- January 4, 2012
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- FGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ALLEGEDLY, PATIENT RECEIVED BURN (NICKEL SIZE) TO THE TIP OF THE PENIS WHILE SCOPE WAS IN USE AND IN CONTACT WITH PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | URETEROSCOPE | FGB | KARL STORZ GMBH & CO. KG | 27011KA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |