FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 371161
·
Received January 10, 2002
Report
- Report Number
- 2020550-2001-00032
- Event Type
- Other
- Date Received
- January 10, 2002
- Date of Event
- April 20, 2001
- Report Date
- January 8, 2002
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- FBJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CO WAS CONTACTED BY PT'S ATTORNEY WHO REPORTED THAT "A FIRE BROKE OUT ON THE OPERATING TABLE DURING THE USE OF A HYSTEROSCOPE AND RESECTOSCOPE." AFTER CONTACTING HOSP, THE CO WAS TOLD THAT A HIGH FREQUENCY CORD WAS BLOWN FROM THE CONNECTOR AND A SPARK MADE CONTACT WITH INCONTINENCE PAD. PAD CAUGHT ON FIRE CAUSING INJURIES TO THE PT. PROCEDURE CANCELLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | HIGH FREQUENCY CORD | FBJ | KARL STORZ GMBH & CO. KG | 277KB | CK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |