MalfunctionFCR
XENON LIGHT SOURCE/FLASH
Received Feb 26, 2019 · Event occurred Oct 3, 2018
Report 8369613 · MDR key 8369613
Device
Generic name
Light Source, Photographic, Fiberoptic
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
20133120Product problems
- Material Discolored
- Device Emits Odor
- Failure to Power Up
- Smoking
- Material Deformation
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPLAINT OF DEVICE EMITTED SMOKE CONFIRMED BASED ON VISUAL OBSERVATIONS + ODOR PRESENT. DEVICE TURNED ON BUT WOULD NOT ILLUMINATE BULB. FOUND INTERNAL FUSE F1 OPEN ON XENON LAMP POWER SUPPLY BOARD. OBSERVATION OF COMPONENT CAPACITOR C4 ON XENON LAMP POWER SUPPLY INDICATES A FAILURE/THERMAL EVENT TOOK PLACE. COMPONENT IS DISCOLORED AND PLASTIC IS DISFIGURED. DEVICE WAS IN USE AT TIME OF EVENT IN OPERATING ROOM. A CODE RED ¿ FIRE/SMOKE RESPONSE BY STAFF AND EMERGENCY SERVICES TOOK PLACE.