n.a. 11573TRecalls & reported problems
Karl Storz GmbH & Co. KG · Stone Extractor, 0.6 mm, 4 wires · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551276921), received between Jul 16, 2021 and Sep 23, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Mechanical Jam
Patient problems: Insufficient Information
MAUDE report 50876095 ↗InjurySep 23, 2026Mechanical Jam
Patient problems: Insufficient Information
MAUDE report 50876094 ↗MalfunctionJul 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED: "DURING DILATION OF PAROTID STRICTURES STRAIGHT BY SIALOENDOSCOPY, THE DISTAL END IN PLASTIC TIP OF THE BASKET PROBE HAS TORN ABOUT 4MM AND GOT STUCK IN THE STÉNON CANAL. PATIENT SUFFERS FROM PAIN AND WAS PRESCRIBED CORTICOSTEROIDS. THIS INCIDENT WAS DECLARED TO THE ANSM. "
Patient problems: Insufficient Information
MAUDE report 12185470 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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