TAKE-APART 26167FGERecalls & reported problems
Karl Storz GmbH & Co. KG · Working Insert, 5x · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551095270), received between Oct 31, 2025 and Oct 31, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Electrical /Electronic Property Problem2
- Electrical Shorting2
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.
MalfunctionOct 31, 2025Break; Electrical /Electronic Property Problem; Electrical Shorting; Break; Electrical /Electronic Property Problem; Electrical Shorting
IT HAS BEEN CONFIRMED THAT THE TWO WORKING INSERTS INVOLVED IN THE REPORTED SHORT-CIRCUIT INCIDENT DURING THE PROCEDURE ARE NON-KARL STORZ PRODUCTS. HOWEVER, THE EVENT REMAINS REPORTABLE, AS IT CANNOT BE CONCLUSIVELY RULED OUT THAT KARL STORZ DEVICES MAY HAVE CONTRIBUTED TO OR INFLUENCED THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438669 ↗MalfunctionOct 31, 2025Break; Electrical /Electronic Property Problem; Electrical Shorting; Break; Electrical /Electronic Property Problem; Electrical Shorting
INITIALLY IT WAS REPORTED THAT THE WORKING INSERTS WERE NON-KARL STORZ PRODUCTS, BUT UPON RETURN AND INVESTIGATION OF THE CONCERNED WORKING INSERTS AT THE MANUFACTURER'S SITE, IT WAS FOUND THAT THE WORKING INSERTS ARE INDEED KARL STORZ PRODUCTS (ARTICLE# (B)(4)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438654 ↗
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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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