MalfunctionGCT
VISERA PRO XENON LIGHT SOURCE
Received Jun 5, 2026 · Event occurred May 29, 2026
Report 3002808148-2026-19490 · MDR key 25414722
Device
Generic name
Light Source, Endoscope, Xenon Arc
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
CLV-S40PROProduct problems
- Activation Failure
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: (B)(6). 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 UNABLE TO LIGHT ON DURING REPROCESSING INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.