MalfunctionPGU
ENDOSCOPE POSITION DETECTING UNIT
Received Jul 20, 2026 · Event occurred Jul 10, 2026
Report 3002808148-2026-24654 · MDR key 25875732
Device
Generic name
Endoscope Position Detecting Unit
Manufacturer
Shirakawa Olympus Co., Ltd.Model number
UPD-3Product problems
- Poor Quality Image
- Communication or Transmission Problem
Patient
NA · 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
THE CUSTOMER REPORTED THE SCOPE DETECTION FAILURE IN DISH OPERATING RANGE AND IMAGE DEGRADED GREY TURN BLACK DURING INSPECTION FOR USE INVOLVING AN OLYMPUS ENDOSCOPE POSITION DETECTING UNIT. THERE WAS NO PATIENT INJURY REPORTED.