FDA Adverse Event
Malfunction
Summary report: N
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE
MDR report key: 1013976
·
Received March 11, 2008
Report
- Report Number
- 2936485-2008-00013
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 12, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FFS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LIGHT CABLES ARE GETTING HOT WHERE THEY ATTACH TO THE SCOPE. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER HAS HAD ISSUES WITH DRAPES CATCHING ON FIRE DUE TO THE LIGHT CABLE BURNING THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE | CABLE | FFS | STRYKER ENDOSCOPY SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |