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n.a. 27050ERecalls & reported problems

Karl Storz GmbH & Co. KG · Working Element · Class 2

Adverse event reports
11
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551077542), received between May 8, 2019 and May 27, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Sparking” (4 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 3 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Sparking4
  • Temperature Problem3
  • Arcing2
  • Excessive Heating2
  • Thermal Decomposition of Device2
  • Product Quality Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Burn(s)2
  • Dysuria2
  • Blister1
  • Insufficient Information1
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 27, 2026Sparking

    IT WAS REPORTED THAT THE CABLE SPARKED AT THE CONNECTION BETWEEN THE CABLE AND THE INSTRUMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25306675 ↗
  • InjuryMay 22, 2026Thermal Decomposition of Device

    IT WAS REPORTED THAT "2 LOOPS ARE GETTING BROKEN WITHIN 10 MINUTES OF SURGERY. THE USER OBSERVED A BURN MARK ON THE WHITE PART OF THE WORKING ELEMENT AND REQUESTED INSPECTION TO EVALUATE WHETHER IT COULD BE RELATED TO THE REPORTED POST-OPERATIVE DYSURIA. THE PATIENT WAS KEPT ON URINE ALKALIZER & PAIN MEDICATION, AND NO HOSPITALIZATION WAS EXTENDED DUE TO THIS ISSUE." CROSS REFERENCE MDR: 9610617-2026-01179, 9610617-2026-01180.

    Patient problems: Dysuria

    MAUDE report 25262708 ↗
  • InjuryMay 22, 2026Thermal Decomposition of Device

    IT WAS REPORTED THAT "2 LOOPS ARE GETTING BROKEN WITHIN 10 MINUTES OF SURGERY. THE USER OBSERVED A BURN MARK ON THE WHITE PART OF THE WORKING ELEMENT AND REQUESTED INSPECTION TO EVALUATE WHETHER IT COULD BE RELATED TO THE REPORTED POST-OPERATIVE DYSURIA. THE PATIENT WAS KEPT ON URINE ALKALIZER & PAIN MEDICATION, AND NO HOSPITALIZATION WAS EXTENDED DUE TO THIS ISSUE." CROSS REFERENCE MDR: 9610617-2026-01179 9610617-2026-01180.

    Patient problems: Dysuria

    MAUDE report 25262705 ↗
  • InjuryNov 19, 2025Arcing; Arcing

    IT WAS REPORTED THAT A RESECTOSCOPE BURNT AND ARCED DURING A CASE. THE CSSD DEPARTMENT HAS DECONTAMINATED THE INSTRUMENT AND THE YELLOW LOOP THAT WAS FUSED INTO THE INSTRUMENT. NO ONE WAS INJURED DURING THIS INCIDENT, BOTH SURGEON AND PATIENT WERE OK. THE INSTRUMENT WAS REPLACED TO COMPLETE THAT TURP PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. A DELAY OR PROLONGATION OF 30-60MIN WAS REPORTED. CROSS REFERENCE MDR: 9610617-2025-02115.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23599676 ↗
  • InjuryNov 19, 2025Arcing; Arcing

    IT WAS REPORTED THAT A RESECTOSCOPE BURNT AND ARCED DURING A CASE. THE CSSD DEPARTMENT HAS DECONTAMINATED THE INSTRUMENT AND THE YELLOW LOOP THAT WAS FUSED INTO THE INSTRUMENT. NO ONE WAS INJURED DURING THIS INCIDENT, BOTH SURGEON AND PATIENT WERE OK. THE INSTRUMENT WAS REPLACED TO COMPLETE THAT TURP PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. A DELAY OR PROLONGATION OF 30-60MIN WAS REPORTED. CROSS REFERENCE MDR: 9610617-2025-02115.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23599674 ↗
  • InjuryJun 24, 2025Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT PATIENT EXPRESSED A BURNING SENSATION DURING THE POST-SURGERY FOLLOW-UP. DUE TO THE BURNING INJURY THIS CASE IS DEEMED REPORTABLE.

    Patient problems: Burn(s)

    MAUDE report 22322613 ↗
  • MalfunctionMay 5, 2025Sparking; Sparking

    IT WAS REPORTED THAT THE UROLOGIST WAS RESECTING WHILE USING 27050E, 277KB AND A VALLEY LAB ESU. WHILE RESECTING, HE NOTICED A SPARK WHERE THE 277KB CONNECTS TO THE 27050E. THIS WAS A ONE TIME SPARK. NO PATIENT WAS HARMED. NO HOSPITAL STAFF WAS HARMED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MEDWATACH 9610617-2025-00783.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21961252 ↗
  • MalfunctionOct 10, 2024Sparking; Temperature Problem; Sparking; Temperature Problem

    IT WAS REPORTED THAT DURING TURP CASE IN (B)(6) 2024 (EXACT DATE WAS NOT PROVIDED), THE RESECTOSCOPE HANDPIECE MADE SPARKS AND CAUSED THE SIDE TO MELT INTERNALLY, AND A DARK SPOT TO FORM. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP DEVICE WITH NO DELAY. NO PATIENT IMPACT WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 20424335 ↗
  • MalfunctionJul 8, 2024Sparking; Temperature Problem; Sparking; Temperature Problem

    IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE ON (B)(6) 2024, SOMETHING CAUSED A SPARK WHEN USING THE MONOPOLAR CABLE AND WORKING ELEMENT. THERE WAS NO PATIENT NOR USER HARM REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP DEVICE, THIS CAUSED A DELAY OF ABOUT 15 MINUTES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19697787 ↗
  • MalfunctionFeb 17, 2023Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

    IT WAS REPORTED THAT THERE WAS AN EVENT WITH A 27050E MONOPOLAR WORKING ELEMENT. ACCORDING TO THE INFORMATION RECEIVED, DOCTOR BURNED HER HAND WHEN TOUCHING THE CASING (WHITE PLASTIC PART ON THE WORKING ELEMENT) IT WAS EXTREMELY HOT. THE SHAFT WAS NOT HOT. THE FACILITY STATED THE DOCTOR HAD A SECOND DEGREE BURN WITH BLISTERS.

    Patient problems: Blister; Burn(s)

    MAUDE report 16396754 ↗
  • MalfunctionMay 8, 2019Product Quality Problem; Product Quality Problem

    ALLEGEDLY, DURING A TRANSURETHRAL REMOVAL OF A PROSTATE TUMOR, WHEN THE DOCTOR SEEDED THE LOOP INTO THE WHITE BLOCK TO LOCK THE ELECTRODE, IT POPPED OUT. HE TRIED A 2ND TIME AND IT POPPED OUT AGAIN, ON THE 3RD TRY WHEN IT POPPED OUT, IT PULLED AND DISLODGED THE URETHRA. AN INTERNAL CATHETER WAS PLACED IN THE PATIENT.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 8592948 ↗

Other HYSTEROSCOPE (AND ACCESSORIES) devices

All HYSTEROSCOPE (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.