n.a. 26158BERecalls & reported problems
Karl Storz GmbH & Co. KG · Bipolar Vaporization Electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551094204), received between Oct 27, 2023 and Jul 12, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (3 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
- Material Fragmentation3
- Break1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2024Break; Material Fragmentation; Break; Material Fragmentation
THE FOIT WAS REPORTED THAT THERE WAS A BREAKAGE OF THE BIPOLAR ELECTRODE IN THE FIRST INTERVENTION. THE SURGICAL PROCEDURE WAS DELAYED FOR 5 MINUTES AND THE BIPOLAR ELECTRODE WAS REMOVED WITH FORCEPS. NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730688 ↗InjuryOct 27, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE INFORMATION RECEIVED, DURING THE PERFORMANCE OF A HYSTEROSCOPIC PROCEDURE, USING THE BIPOLAR ELECTRODE IN QUESTION TO ELECTROCUTE A NABOTH CYST, THERE WAS A SUDDEN DETACHMENT OF THE ACTIVE PART OF THE SAID ELECTRODE, WHICH INSTANTLY FRAGMENTED, MAKING IT IMPOSSIBLE TO RECOVER ANY FRAGMENTS IN THE UTERUS.
Patient problems: Foreign Body In Patient
MAUDE report 18023092 ↗InjuryOct 27, 2023Material Fragmentation; Material Fragmentation
ACCORDING TO THE INFORMATION RECEIVED, DURING THE PERFORMANCE OF A HYSTEROSCOPIC PROCEDURE, USING THE BIPOLAR ELECTRODE IN QUESTION TO ELECTROCUTE A NABOTH CYST, THERE WAS A SUDDEN DETACHMENT OF THE ACTIVE PART OF THE SAID ELECTRODE, WHICH INSTANTLY FRAGMENTED, MAKING IT IMPOSSIBLE TO RECOVER ANY FRAGMENTS IN THE UTERUS.
Patient problems: Foreign Body In Patient
MAUDE report 18023091 ↗
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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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