FDA Adverse Event
Other
Summary report: N
*
MDR report key: 592371
·
Received April 11, 2005
Report
- Report Number
- 592371
- Event Type
- Other
- Date Received
- April 11, 2005
- Date of Event
- March 24, 2005
- Report Date
- April 11, 2005
- Manufacturer
- NUVASIVE, INC.
- Product Code
- FST
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE, A BIFURCATED FIBEROPTIC LIGHT CABLE BECAME UNUSUALLY HOT. THE LIGHT CABLE IS BUILT IN THE GENERAL SHAPE OF A "Y" ALLOWING ONE LIGHT SOURCE TO PROVIDE LIGHT FOR TWO DIFFERENT SITES AT THE SAME TIME. DURING THIS OPERATION, ONLY ONE LEG WAS BEING USED. THE OTHER LEG WAS EITHER DRAPED OVER A SURFACE OR LEFT HANGING FREE. ONE OF THE O.R. PERSONNEL NOTICED THE UNUSED LEG WAS VERY HOT TO THE TOUCH. THE CABLE WAS REPLACED WITH A SIMILAR ONE AND THE PROBLEM DID NOT REOCCUR. NO HARM WAS DONE TO THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | FIBER OPTIC LIGHT SOURCE CABLE, BIFURCATED | FST | NUVASIVE, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |