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 ↗
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- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
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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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