n.a. 011160-10Recalls & reported problems
Karl Storz GmbH & Co. KG · Electrode, bipolar · Class 2
Quick summary
This Karl Storz bipolar resectoscope electrode is used for prostate and uterine procedures. The 27 reports mostly describe parts breaking or coming apart during surgery, sometimes leaving a fragment inside the patient and forcing the surgeon to cancel or delay the operation; a few mention the electrode smoking or heating. Reports describe 10 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04048438005408), received between Sep 9, 2022 and Aug 5, 2026 — classified as 10 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Break” (16 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break16
- Detachment of Device or Device Component11
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Excessive Heating1
- Misconnection1
- Sparking1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information4
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148148 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148120 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148119 ↗InjuryJul 1, 2026Detachment of Device or Device Component
THE FOLLOWING WAS REPORTED A BIPOLAR RESECTOSCOPE PROCEDURE THAT RESULTED IN A PART OF THE LOOP BREAK OFF INSIDE THE PATIENT'S UTERUS. IT HAD A NEGATIVE IMPACT ON THE PATIENT AND THE SURGEON HAD TO CANCEL FOLLOWING CASE AS A RESULT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25677664 ↗InjuryJul 1, 2026Detachment of Device or Device Component
THE FOLLOWING WAS REPORTED A BIPOLAR RESECTOSCOPE PROCEDURE THAT RESULTED IN A PART OF THE LOOP BREAK OFF INSIDE THE PATIENT'S UTERUS. IT HAD A NEGATIVE IMPACT ON THE PATIENT AND THE SURGEON HAD TO CANCEL FOLLOWING CASE AS A RESULT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25677651 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT "DURING THE TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE OF PATIENT THE PRODUCT "BIPOLAR MTP LOOP ELECTRODE 24/26FR (STERILE), REF. (B)(4)- KARL STORZ" WAS OPENED AND PRESENTED A RUPTURE DURING USE. DUE TO THIS OCCURRENCE, IT WAS NECESSARY TO RETRIEVE A SECOND UNIT FROM THE PHARMACY IN ORDER TO COMPLETE THE PROCEDURE.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236248 ↗InjuryJan 15, 2026Detachment of Device or Device Component; Excessive Heating
THE EVENT OCCURRED IN CANADA. ACCORDING TO THE INFORMATION RECEIVED, STOPPED WORKING, LOUD POP THEN SMOKED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. THE PROCEDURE WAS DELAY APPROXIMATELY 30 MINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24085388 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSULATION TUBE AT THE BASE OF ONE ELECTRODE WAS FOUND DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908275 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THAT THE BIPOLAR HANDLE BROKE INTO TWO PIECES DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-01451.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854387 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THAT THE BIPOLAR HANDLE BROKE INTO TWO PIECES DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-01450.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854386 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THAT THE BIPOLAR HANDLE BROKE INTO TWO PIECES DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854018 ↗InjuryAug 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT INTRACAVITARY FIBROID. TRANSCERVICAL RESECTION PERFORMED. THE PROCEDURE WAS TECHNICALLY CHALLENGING. A SMALL LOOP ELECTRODE FRACTURED DURING THE OPERATION AND WAS IDENTIFIED IMMEDIATELY. THE FRAGMENT, APPROXIMATELY 4 MM IN SIZE, WAS NOT VISIBLE UPON INSPECTION AND IS PRESUMED TO HAVE BEEN EXPELLED WITH THE IRRIGATION FLUID. THE LOOP WAS REPLACED WITH A NEW DISPOSABLE ELECTRODE TO COMPLETE THE PROCEDURE. A CHECK HYSTEROSCOPY WAS PERFORMED AT THE END OF THE PROCEDURE, AND NO FOREIGN BODY WAS IDENTIFIED WITHIN THE ENDOMETRIAL CAVITY. DUE TO THE ADDITIONAL HYSTEROSCOPY THE EVENT IS DEEMED REPORTABLE.
Patient problems: Insufficient Information
MAUDE report 22785146 ↗InjuryAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT INTRACAVITARY FIBROID. TRANSCERVICAL RESECTION PERFORMED. THE PROCEDURE WAS TECHNICALLY CHALLENGING. A SMALL LOOP ELECTRODE FRACTURED DURING THE OPERATION AND WAS IDENTIFIED IMMEDIATELY. THE FRAGMENT, APPROXIMATELY 4 MM IN SIZE, WAS NOT VISIBLE UPON INSPECTION AND IS PRESUMED TO HAVE BEEN EXPELLED WITH THE IRRIGATION FLUID. THE LOOP WAS REPLACED WITH A NEW DISPOSABLE ELECTRODE TO COMPLETE THE PROCEDURE. A CHECK HYSTEROSCOPY WAS PERFORMED AT THE END OF THE PROCEDURE, AND NO FOREIGN BODY WAS IDENTIFIED WITHIN THE ENDOMETRIAL CAVITY. DUE TO THE ADDITIONAL HYSTEROSCOPY THE EVENT IS DEEMED REPORTABLE.
Patient problems: Insufficient Information
MAUDE report 22785117 ↗MalfunctionJul 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LOOP SNAPPED DURING THE PROCEDURE IN THE PATIENT. THE LOOP WAS RETRIEVED, AND THEY SWAPPED THE LOOP FOR ANOTHER TO COMPLETE THE CASE. NO NEGATIVE IMPACT ON STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22571673 ↗MalfunctionJul 22, 2025Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THAT THERE WAS A CONTRACTION OF THE THIGH DURING ACTIVATION OF THE RESECTOSCOPE. NO NEGATIVE IMPACT ON STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565612 ↗MalfunctionJul 8, 2025Break; Break
IN THE TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE MENTIONED MATERIAL BROKE. THEREFORE, A SECOND UNITS WAS USED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22439562 ↗MalfunctionJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INFORMATION RECEIVED, DURING AN OPERATIVE HYSTEROSCOPY, THE GYNAECOLOGIST OBSERVED, UPON FIRST USE OF A SINGLE-USE BIPOLAR RESECTION LOOP, THE INTRAUTERINE PROJECTION OF AN UNUSUAL FRAGMENT THAT APPEARED TO BE A PIECE OF METAL. THE PROCEDURE WAS TEMPORARILY HALTED. THE FRAGMENT WAS RETRIEVED. THE INTEGRITY OF THE RESECTION LOOP WAS CHECKED (INTACT). THE ORIGIN OF THE FRAGMENT WAS TESTED WITH A MAGNET: IT WAS FOUND TO BE "NON-METALLIC," BUT STILL CONSIDERED SUSPICIOUS BY THE SURGEON. THE PROCEDURE WAS HALTED TO INVESTIGATE THE ORIGIN OF THE FOREIGN ELEMENT. THIS LED TO A PROLONGATION OF SURGICAL TIME. A NEW RESECTION LOOP HAD TO BE USED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359673 ↗MalfunctionJun 7, 2025Break; Break
ACCORDING TO THE INFORMATION RECEIVED, DURING THE PROCEDURE THE TIP OF THE ELECTRODE BROKE OFF, WHICH WAS IMMEDIATELY NOTICED BY THE SURGEON. ANOTHER ELECTRODE WAS USED TO COMPLETE THE PROCEDURE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22162848 ↗InjuryMay 21, 2025Break; Break
IT WAS REPORTED THAT BIPOLAR LOOP BROKE DURING USE OUTSIDE OF THE PATIENT'S BODY. THE BROKEN PIECE IS DEEMED TOO SMALL TO X-RAY AND CHECK CYSTOSCOPY WAS CLEAR. ACCORDING TO THE DOCTOR, IT IS HIGHLY UNLIKELY THAT THE TINY LOOP WOULD BE IN THE PATIENT AND THERE IS NO CLINICAL HARM. PATIENT WILL HAVE CHECK CYSTOSCOPY IN A FEW WEEKS AS FOLLOW UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063337 ↗InjuryMay 21, 2025Break; Break
IT WAS REPORTED THAT BIPOLAR LOOP BROKE DURING USE OUTSIDE OF THE PATIENT'S BODY. THE BROKEN PIECE IS DEEMED TOO SMALL TO X-RAY AND CHECK CYSTOSCOPY WAS CLEAR. ACCORDING TO THE DOCTOR, IT IS HIGHLY UNLIKELY THAT THE TINY LOOP WOULD BE IN THE PATIENT AND THERE IS NO CLINICAL HARM. PATIENT WILL HAVE CHECK CYSTOSCOPY IN A FEW WEEKS AS FOLLOW UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22063336 ↗InjuryMay 2, 2025Misconnection; Device Dislodged or Dislocated; Misconnection; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE ELECTRODE WAS NOT FIXED TO THE WORKING ELEMENT AND CONTINUED TO SEPARATE. AS A RESULT OF INSPECTING BOTH PRODUCTS, IT WAS DETERMINED THAT THE ELECTRODE WAS DEFECTIVE. THE SYMPTOM OF THE DEFECT WAS THAT THERE SHOULD HAVE BEEN A FIXING GROOVE, BUT THE GROOVE WAS NOT PROPERLY CREATED. THERE WAS NO DIRECT IMPACT ON THE PATIENT, BUT SINCE THE SURGERY WAS EXTENDED BY ABOUT 40 MINUTES THE EVENT IS DEEMED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952187 ↗InjuryApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, A CONSULTANT WAS USING OUR ELECTRODE FOR UTERINE RESECTION AND THE TOP OF THE ELECTRODE HAD BURNT THE TOP OF THE UTERINE CAVITY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21895319 ↗MalfunctionApr 4, 2025Sparking; Sparking
IT WAS REPORTED THAT DURING SURGERY SPARKS OF FIRE CAME OUT OF THE WORKING ELEMENT AND THE CABLE. NO HARM FOR THE PATIENT OR THE SURGEON. THE SURGERY WAS PROLONGED FOR LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-00553; 9610617-2025-00555.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21780656 ↗MalfunctionFeb 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2025, DURING A TURP PROCEDURE, THE TIP BROKE OFF WHEN INSERTED TO PATIENT, A BACK UP UNIT WAS USED AFTER HAVING RETRIEVED THE BROKEN OFF TIP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21335183 ↗MalfunctionFeb 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED ON (B)(6) 2025 DURING A TURP PROCEDURE, A PIECE OF THE LOOP BROKE INSIDE THE PATIENT. BROKE PIECE WAS REMOVED. THERE WAS NO INJURY TO THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333259 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.