n.a. 30675NDRecalls & reported problems
Karl Storz GmbH & Co. KG · MANHES High Frequency Needle · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551123799), received between Oct 24, 2018 and Apr 2, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Melted” (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
- Melted2
- Thermal Decomposition of Device2
- Break1
- Material Fragmentation1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn, Thermal1
- Injury1
- Tissue Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted
IT WAS REPORTED THAT THE INSULATION MELTED AT THE DISTAL END. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751592 ↗MalfunctionApr 1, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted
IT WAS REPORTED THAT THE INSULATION MELTED AT THE DISTAL END. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21748461 ↗InjuryOct 24, 2018Break; Material Fragmentation; Smoking
ALLEGEDLY, AS PER MEDWATCH #MW5080396 RECEIVED FROM THE FDA, DURING A PROCEDURE IN WHICH A MANHES HIGH FREQUENCY NEEDLE WAS BEING USED, WHEN THE CAUTERY WAS USED, THE SURGEON NOTED A SMALL AMOUNT OF SMOKE AND A FEW SMALL BLACK FRAGMENTS. THE SURGEON REMOVED THE DEVICE AND THEY NOTED A SMALL AREA ON THE INSTRUMENT WHERE THE DEVICE HAD A BREAK IN THE INSULATION APPROXIMATELY 1 CM FROM THE TIP. THE SURGEON THEN EXAMINED THE PATIENT LAPAROSCOPICALLY AGAIN AND NOTED A THROUGH AND THROUGH BURN TO THE PATIENT'S LEFT FALLOPIAN TUBE.
Patient problems: Burn, Thermal; Injury; Tissue Damage
MAUDE report 8002219 ↗
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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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