LITHOCLAST FR-283Recalls & reported problems
E.M.S. Electro Medical Systems S.A. · Swiss LithoClast Trilogy Disposable Probe Ø3.9x350mm · 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 07613353162597), received between Dec 10, 2024 and Dec 10, 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.
MalfunctionDec 10, 2024
SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE BY BOSTON SCIENTIFIC BROKE IN THE MIDDLE OF A PERCUTANEOUS NEPHROLITHOTOMY. THE SHEATH BROKE NEAR THE BASE OF THE SUPPLY ITEM. A NEW PROBE WAS OPENED TO CONTINUE THE PROCEDURE. NO PATIENT HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20891638 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.