MalfunctionFSR
ULTRALITE PRO HEADLAMP
Received Apr 29, 2011
Report 1222895-2011-00008 · MDR key 2097493
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem
THE CUSTOMER REPORTS THAT THE BOTTOM PART OF THE LAMP MODULE FELL INTO THE PT'S WOUND WHEN THE SURGEON WAS ADJUSTING THE LIGHT OUTPUT. THIS OCCURRED DURING A POSTERIOR LUMBAR FUSION. NO PT INJURY.