FDA Adverse Event
Malfunction
Summary report: N
5.0MM X 10FT FIBEROPTIC LIGHT CABLE
MDR report key: 1075820
·
Received July 10, 2008
Report
- Report Number
- 2936485-2008-00057
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 13, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FFS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE FOLLOWING WAS REPORTED BY THE SALES REPRESENTATIVE: "THE POWER OF THE X7000 LIGHT SOURCE COMBINED WITH A STRYKER LIGHT CORD (PART#233 050 090) MELTED THE CAMERA DRAPE AND BURNED THROUGH THE SURGEON'S GLOVE WHEN CONNECTED TO A MEDTRONIC NEURO PEN SCOPE. THE CONNECTION PIECE BETWEEN THE SCOPE AND LIGHT CORD BECOME EXTREMELY HOT AND CAUSED THE ABOVE MENTIONED MELTING. THERE WAS NO HARM TO THE PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM X 10FT FIBEROPTIC LIGHT CABLE | FIBEROPTIC CABLE | FFS | STRYKER ENDOSCOPY SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |