FDA Adverse Event
Other
Summary report: N
1221826-2007-00001
MDR report key: 812756
·
Received January 11, 2007
Report
- Report Number
- 1221826-2007-00001
- Event Type
- Other
- Date Received
- January 11, 2007
- Product Code
- FFZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
LIGHT CABLE WAS IN GOOD WORKING ORDER DURING AND AFTER PROCEDURE. HOSPITAL STATED THERE WAS NO DEVICE MALFUNCTION. WE FOUND NO PROBLEM WITH THE LIGHT CABLE. ALL KARL STORZ LIGHT CABLES COME WITH CARE AND MAINTENANCE INSTRUCTIONS THAT INCLUDE THE WARNING STATEMENT: "NEVER LEAVE THE ENDOSCOPE CONNECTION OF THE CABLE LAYING ON A DRAPE WITH THE LIGHT SOURCE TURNED ON, AS SURGICAL DRAPES MAY BE POTENTIALLY FLAMMABLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FFZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |