FDA Adverse Event
Other
Summary report: N
KARL STORZ LIGHT CABLE
MDR report key: 567268
·
Received January 17, 2005
Report
- Report Number
- 2020550-2005-00001
- Event Type
- Other
- Date Received
- January 17, 2005
- Date of Event
- November 17, 2004
- Report Date
- January 17, 2005
- Manufacturer
- KARL STORZ ENDOVISION
- Product Code
- FFZ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT IN O.R. FOR DIAGNOSTIC LAPAROSCOPY. LIGHT SOURCE TURNED ON (CIRCULATOR THOUGH SHE HEARD TO TURN IT ON). LIGHT SOURCE WAS NOT READY TO BE USED SO CABLE WAS LAID ON DRAPE COVERING PT FACE. LIGHT CABLE BURNED HOLE IN DRAPE AND PT SUSTAINED BURN TO LEFT CHEEK. PT SEEN BY PLASTIC SURGEON. BURN APPEARS TO BE THIRD DEGREE AT CENTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ LIGHT CABLE | LIGHT CABLE | FFZ | KARL STORZ ENDOVISION | 495NL | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other |