MalfunctionLFS
PKG, X8000 LIGHTSOURCE
Received Sep 27, 2006 · Event occurred Sep 1, 2006
Report 2936485-2006-00065 · MDR key 866838
Device
Generic name
Lightsource
Manufacturer
Stryker Endoscopy San JoseModel number
*Catalog number
0220200000
Lot number
*
Product problems
- Thermal Decomposition of Device
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LIGHTSOURCE WAS USED FOR A FEW MINUTES AND THE LIGHT WENT OUT. THERE WAS A BURNING SMELL.
Additional Manufacturer Narrative
DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.