n.a. 26159BERecalls & reported problems
Karl Storz GmbH & Co. KG · Bipolar Dissection Electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551094228), received between Aug 20, 2020 and Jun 18, 2025 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Arcing of Electrodes” (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
- Arcing of Electrodes2
- Break2
- Detachment of Device or Device Component2
- Insufficient Device Problem Information1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- Foreign Body In Patient3
- Insufficient Information3
- Superficial (First Degree) Burn2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, DURING THE RESECTION OF A SEPTUM ON A FEMALE PATIENT, THE SURGEON USED THE 26159BE ELECTRODE WITH A TROPHYSCOPE, CONNECTED TO A VALLEYLAB FT10 GENERATOR. THE TECHNICAL NURSE REPORTED THAT FRAGMENTS OF THE ELECTRODE SHEATH WERE FOUND INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22288043 ↗InjuryOct 28, 2024Break; Break
IT WAS REPORTED DURING A HYSTEROSCOPY PROCEDURE, THE TIP OF THE INSTRUMENT BROKE AND THE BROKEN PIECE REMAINED INSIDE THE ENDOMETRIUM OF THE PATIENT. THE PIECE WAS NOT RECOVERED.
Patient problems: Insufficient Information
MAUDE report 20547345 ↗InjuryOct 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED DURING A HYSTEROSCOPY PROCEDURE, THE TIP OF THE INSTRUMENT BROKE AND THE BROKEN PIECE REMAINED INSIDE THE ENDOMETRIUM OF THE PATIENT. THE PIECE WAS NOT RECOVERED.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20546879 ↗InjuryJun 25, 2024Arcing of Electrodes; Arcing of Electrodes
IT WAS REPORTED THAT DURING THE SURGERY, AN INTRACAVITARY FLASH OCCURRED. THE BIPOLAR ELECTRODE WAS STUCK INSIDE THE HYSTEROSCOPE SHEATH. AS A RESULT, THE PATIENT HAD A SUPERFICIAL ENDOMETRIAL BURN.
Patient problems: Superficial (First Degree) Burn
MAUDE report 19608433 ↗InjuryJun 25, 2024Arcing of Electrodes; Arcing of Electrodes
IT WAS REPORTED THAT DURING THE SURGERY, AN INTRACAVITARY FLASH OCCURRED. THE BIPOLAR ELECTRODE WAS STUCK INSIDE THE HYSTEROSCOPE SHEATH. AS A RESULT, THE PATIENT HAD A SUPERFICIAL ENDOMETRIAL BURN.
Patient problems: Superficial (First Degree) Burn
MAUDE report 19608321 ↗MalfunctionJan 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): THE ELECTRODE WAS LOOSENED DURING THE SURGERY. THE ELECTRODE STAYED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11151528 ↗MalfunctionAug 20, 2020Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): WHEN THE DOCTOR IS OPERATING WITH 26159BE BIPOLAR DISSECTING ELECTRODE, MIDDLE PART OF THE ELECTRODE INSULATOR CAME OFF DURING THE PROCEDURE, RESULTING IN FOREIGN BODY IN PATIENT'S BODY. PART GOT RETRIEVED - NO HARM TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10432052 ↗
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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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