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n.a. 27040ERecalls & reported problems

Karl Storz GmbH & Co. KG · Working Element · Class 2

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551075609), received between Feb 27, 2023 and Feb 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Sparking” (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

  • Sparking1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryFeb 27, 2023Sparking; Sparking

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A WORKING ELEMENT. DURING AN INTERVENTION, SPARKING HAS ALREADY OCCURRED REPEATEDLY IN THE HF APPLICATION. ACCORDING TO THE USER, THE HF DEVICE AND HF CABLE CONNECTIONS WERE REPLACED DURING THE PROCEDURE AND THE FAULT CONTINUED TO OCCUR. AFTER THE INITIAL RECORDING OF THE FAULT, THE CUSTOMER THINKS THAT THE FAULT CAN BE LOCALIZED IN THE CABLE CONNECTION WITH THE STORZ RESECTOSCOPE / MONOPOLAR HF LOOP.

    Patient problems: Insufficient Information

    MAUDE report 16444600 ↗

Other HYSTEROSCOPE (AND ACCESSORIES) devices

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Sources and updates

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