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n.a. 27093LL-SRecalls & reported problems

Karl Storz GmbH & Co. KG · PROBE,STERILE,ULTRASONIC · 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 04048551394182), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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.

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 21, 2018Material Separation; Material Separation

    ALLEGEDLY, DURING A PERCUTANEOUS NEPHROLITOMY PROCEDURE, THREE PIECES OF TIP OF THE ULTRASONIC PROBE BROKE OFF INTO THE PATIENT. THE BROKEN PIECES WERE RETRIEVED AND PROCEDURE WAS COMPLETED USING A DIFFERENT PROBE. HOSPITAL CONFIRMED THERE WAS NO INJURY TO PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8096620 ↗

Other Lithotriptor, ultrasonic devices

All Lithotriptor, ultrasonic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.