FDA Adverse Event
Other
Summary report: N
*
MDR report key: 968874
·
Received May 8, 2006
Report
- Report Number
- 2027009-2006-00026
- Event Type
- Other
- Date Received
- May 8, 2006
- Manufacturer
- KARL STORZ IMAGING, INC.
- Product Code
- GCJ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
UPON INITIAL EVAL OF THE CAMERA HEAD, THE CHASSIS CONNECTOR CARD EDGE HAS BURN MARKS . WE SUSPECT THE CARD EDGE WAS WET AND DID NOT COMPLETELY DRY WHEN PLUGGED INTO THE CAMERA CONTROL UNIT WHICH CAN LEAD TO ELECTRICAL SHORT AND RESULT IN INTERFERENCE IN THE IMAGE. BECAUSE THE FACILITY DID NOT HAVE A BACK-UP CAMERA AVAILABLE, THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | GCJ | KARL STORZ IMAGING, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |