TAKE-APART 26184HMRecalls & reported problems
Karl Storz GmbH & Co. KG · TAKE-APART® Bipolar Ring Handle · 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 04048551102886), received between Jun 12, 2025 and Sep 19, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Electrical /Electronic Property Problem; Detachment of Device or Device Component; Electrical /Electronic Property Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE "THE INSTRUMENT WAS ASSEMBLED AS PER THE GUIDANCE GIVEN BY THE STORZ AND THERE WAS NO CURRENT ACROSS THE FORCEPS TIP. THE CABLE AND INSERT WERE SWAPPED FOR NEW ONES BUT THIS DID NOT RESOLVE THE ISSUE. THE CAUTERY DEVICE HAS BEEN CHECKED AND IS WORKING WITH OTHER INSTRUMENTS. THE PROCEDURE WAS UNABLE TO BE PERFORMED. WE HAD TO PERFORM A FULL COELIOTOMY IN ORDER TO PERFORM AN OVARIOHYSTERECTOMY."THE ISSUE OCCURRED DURING USE IN A VETERINARY PROCEDURE AND THERE WAS NO NEGATIVE HEALTH IMPACT FOR ANY HUMAN ALLEGED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 23099267 ↗InjuryJun 12, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPAY IN A CANINE PATIENT THE BIPOLAR SET WAS NOT WORKING. THE CAUTERIZATION DID NOT WORK. THE PRODUCT WAS STRIPPED DOWN AND THE INSERT TAKEN OUT. A BRAND-NEW INSERT AND NEW WIRE WAS USED AND STILL IT DID NOT WORK. IN THE END THE PROCEDURE WAS REVERTED TO PLACING A BIGGER PORT IN AND USING THE VET SEAL. THIS WORKED FINE. THE SURGERY WAS PROLONGED FOR MORE THAN 60 MINUTES. THE PATIENT HAD A SLOW RECOVERY DUE TO PROLONGED ANESTHETICS. CROSS REFERENCE MDR: 9610617-2025-01014, 9610617-2025-01015.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22198378 ↗InjuryJun 12, 2025Appropriate Device Problem Term/Code Not Available; Activation Failure; Appropriate Device Problem Term/Code Not Available; Activation Failure
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPAY IN A CANINE PATIENT THE BIPOLAR SET WAS NOT WORKING. THE CAUTERIZATION DID NOT WORK. THE PRODUCT WAS STRIPPED DOWN AND THE INSERT TAKEN OUT. A BRAND-NEW INSERT AND NEW WIRE WAS USED AND STILL IT DID NOT WORK. IN THE END THE PROCEDURE WAS REVERTED TO PLACING A BIGGER PORT IN AND USING THE VET SEAL. THIS WORKED FINE. THE SURGERY WAS PROLONGED FOR MORE THAN 60 MINUTES. THE PATIENT HAD A SLOW RECOVERY DUE TO PROLONGED ANESTHETICS. CROSS REFERENCE MDR: 9610617-2025-01014, 9610617-2025-01015.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22198377 ↗
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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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