n.a. 26050ERecalls & reported problems
Karl Storz GmbH & Co. KG · Working Element · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551092293), received between Mar 6, 2023 and Mar 30, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Sparking2
- Break1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Burn(s)2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Sparking
IT WAS REPORTED THAT SPARKS AT THE WHITE CONNECTOR, BROWN SPOT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24733311 ↗MalfunctionDec 8, 2025Sparking; Sparking
IT WAS REPORTED THAT THE SCRUB TEAM SETTING UP THE INSTRUMENT, PLUGGED IN THE KARL STORZ DIATHERMY CABLE INTO THE WORKING ELEMENT WHEN SPARKS OCCURRED AND A BURNING SMELL. THE DIATHERMY MACHINE IMMEDIATELY SWITCH OFF, THE CABLE WAS THEN REMOVED AND BOTH INSTRUMENTS PLACED TO ONE SIDE. DELAY OF PROCEDURE 15-30 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744787 ↗MalfunctionFeb 3, 2025Break; Mechanics Altered; Break; Mechanics Altered
IT WAS REPORTED THAT THERE WAS A BREAKAGE WITHIN THE SHAFT AND CORROSION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294700 ↗InjuryMar 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD BURNS ON THE INTROITUS VAGINAE (VESTIBULUM) AND AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Patient problems: Burn(s)
MAUDE report 16487179 ↗InjuryMar 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD BURNS ON THE INTROITUS VAGINAE (VESTIBULUM) AND AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Patient problems: Burn(s)
MAUDE report 16486666 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.