MalfunctionHET
Video telescope "ENDOEYE HD II", 5.4 mm, 0°, autoclavable
Received Jul 31, 2026
Report 9610773-2026-05258 · MDR key 50100364
Device
Product problems
- Gas/Air Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer reported a failed leak test involving an Olympus rigid video laparoscope. There was no patient injury reported.
Additional Manufacturer Narrative
The device was returned to Olympus for inspection and the reported failure was no confirmed. A root cause could not be identified. Based on the results of the investigation, the most probable cause of the reported event could not be determined. Should additional relevant information become available, a supplemental report will be submitted. Olympus will continue to monitor field performance for this device.