MalfunctionFCQ
HALOGEN LIGHT SOURCE
Received Jun 22, 2026 · Event occurred Apr 7, 2026
Report 3002808148-2026-21331 · MDR key 25587247
Device
Generic name
Light Source, Incandescent, Diagnostic
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
CLH-250Product problems
- Poor Quality Image
- Gas/Air Leak
Patient
36 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT A WATER INVASION HAD BEEN FOUND AND THAT THE LENS IMAGE WAS FOGGY DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE INVOLVING AN OLYMPUS HALOGEN LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.