MalfunctionGCT
VISERA 4K UHD XENON LIGHT SOURCE
Received May 18, 2026 · Event occurred Apr 30, 2026
Report 3002808148-2026-16569 · MDR key 25209762
Device
Generic name
Light Source, Endoscope, Xenon Arc
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
CLV-S400Product problems
- Poor Quality Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
IT WAS REPORTED THAT THE XENON LIGHT SOURCE PRODUCED A LOW-BRIGHTNESS IMAGE. THE ISSUE WAS IDENTIFIED DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.