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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

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