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n.a. 27068L-SRecalls & reported problems

Karl Storz GmbH & Co. KG · KNIFE,HALF-ROUND,STERILE · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 04048551394335), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionJan 6, 2022Break

    WHILE DOING CYSTOSCOPY, ROUND COLD KNIFE BLADE BROKE INSIDE PATIENT. DOCTOR RETRIEVED IT, XRAY TAKEN.

    Patient problems: Foreign Body In Patient

    MAUDE report 13175523 ↗

Other Urethrotome devices

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Sources and updates

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