EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Received Jul 31, 2026 · Event occurred Jul 6, 2026
Report 3002808148-2026-26420 · MDR key 50100395
Device
Product problems
- Crack
- Material Puncture/Hole
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer returned the Ultrasound Gastrovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates a pinhole on the cement, a cracked adhesive, and missing adhesive. There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to Olympus for inspection. A root cause could not be identified. Based on the results of the investigation, it is likely the following led to the malfunction: The most probable cause for the malfunction was traced to component failure. Should additional relevant information become available, a supplemental report will be submitted. Olympus will continue to monitor field performance for this device.