n.a. 27040DRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551075470), received between Aug 26, 2025 and Aug 26, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Excessive Heating” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Excessive Heating2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT BOTH THE RESECTOSCOPE AND THE CABLE OVERHEATED DURING THE PROCEDURE, GIVING OFF A BURNT SMELL. AS THE HOSPITAL DID NOT HAVE A REPLACEMENT DEVICE AVAILABLE, THEY BORROWED ONE FROM ANOTHER HOSPITAL. CONSEQUENTLY, THE OPERATION WAS PAUSED FOR 45 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPLACEMENT DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. SINCE THE PROCEDURE WAS PROLONGED FOR 45 MINUTES, THE CASE IS DEEMED AS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22896091 ↗MalfunctionAug 26, 2025Excessive Heating; Excessive Heating
IT WAS REPORTED THAT BOTH THE RESECTOSCOPE AND THE CABLE OVERHEATED DURING THE PROCEDURE, GIVING OFF A BURNT SMELL. AS THE HOSPITAL DID NOT HAVE A REPLACEMENT DEVICE AVAILABLE, THEY BORROWED ONE FROM ANOTHER HOSPITAL. CONSEQUENTLY, THE OPERATION WAS PAUSED FOR 45 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPLACEMENT DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. SINCE THE PROCEDURE WAS PROLONGED FOR 45 MINUTES, THE CASE IS DEEMED AS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895667 ↗
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- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
- Myosure Reach Tissue Removal Device 10-401FCHologic, Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
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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