SHOCKPULSE-SE LITHOTRIPSY SYSTEM
Received Jul 27, 2026 · Event occurred Jun 23, 2026
Report 3011050570-2026-00758 · MDR key 50007760
Device
Product problems
- Visual Prompts will not Clear
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer reported broken generator that gave error message during an unspecified procedure involving an Olympus LITHOTRIPSY SYSTEM. There was no patient injury reported.
Additional Manufacturer Narrative
This MDR was submitted during the system outage from July 22, 2026 to July 27, 2026 which may result in a delay of receipt of all of the acknowledgements.The device was returned to Olympus for inspection and the reported failure was confirmed.A root cause could not be identified. Based on the results of the investigation, it is likely the following led to the malfunction: Caused 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.