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NA 8416031Recalls & reported problems

Richard Wolf GmbH · CUTTING ELECTRODE MONO 14.5FR 0° for resectoscope, telescope Ø 2.7mm, stem color: yellow, for sheaths, intermittent irrigation 14,5Fr, loop: round, PACK=1 PC, for MIDI-size resectoscope, unsterile, reusable · 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 04055207017074), received between Mar 16, 2018 and Mar 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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

  • Overheating of Device1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionMar 16, 2018Overheating of Device; Overheating of Device

    SUSPECT DEVICE WAS USED ON A TUMOR ON A CHILDS SMALL INTESTINE. THE LOOP COMPLETELY DEGRADED AND WAS NEVER FOUND AGAIN. PROCEDURE WAS COMPLETED.

    Patient problems: No Information

    MAUDE report 7347249 ↗

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