MalfunctionGCT
XENON LAMP
Received Jun 22, 2026
Report 3002808148-2026-21346 · MDR key 25587908
Device
Generic name
Light Source, Endoscope, Xenon Arc
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
MD-631Product problems
- Output below Specifications
- Output Problem
- Activation Failure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE AVAILABLE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED LOW LIGHT DURING MAINTENANCE INVOLVING AN OLYMPUS XENON LAMP. THERE WAS NO PATIENT INJURY REPORTED.