MalfunctionGCT
VISERA PRO XENON LIGHT SOURCE
Received Jun 9, 2026 · Event occurred May 15, 2026
Report 3002808148-2026-19913 · MDR key 25452289
Device
Generic name
Light Source, Endoscope, Xenon Arc
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
CLV-S40PROProduct problems
- No Display/Image
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE IMAGE DID NOT DISPLAY DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.
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.