SHOCKPULSE LITHOTRIPSY FOOTSWITCH
Received Jul 27, 2026
Report 3011050570-2026-00759 · MDR key 50008634
Device
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer returned the LITHOTRIPSY FOOTSWITCH, which is an Olympus asset with no reported complaint. During the evaluation of the device, exposed wires was observed. The Service Repair indicated that the most likely cause of the exposed wires was due to component failure. There was no patient involvement.
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: Cause 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.