LITHOCLAST FR-286Recalls & reported problems
E.M.S. Electro Medical Systems S.A. · Swiss LithoClast Trilogy Disposable Probe Ø3.4x445mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613353162627), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2024
AS WE WERE USING THE PRODUCT, IT BROKE IN HALF. BOTH PIECES WERE REMOVED FROM THE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577450 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.