Skip to content

n.a. 277KBRecalls & reported problems

Karl Storz GmbH & Co. KG · Unipolar High Frequency Cord, 300 cm · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
17
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04048551090169), received between Dec 20, 2018 and Mar 11, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Sparking” (7 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: 1 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 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

  • Sparking7
  • Break3
  • Detachment of Device or Device Component3
  • Material Separation3
  • Electrical /Electronic Property Problem2
  • Overheating of Device2
  • Temperature Problem2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • Insufficient Information4
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 11, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE MONOPOLAR CABLE EXHIBITED AN INTERNAL SPLIT. THE LEAD HAD DETACHED FROM WITHIN THE CONNECTION HEAD WHILE IT WAS ATTACHED TO THE SURGICAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24573508 ↗
  • MalfunctionFeb 25, 2026Overheating of Device

    IT WAS REPORTED THAT THE SINGLE-POLE CABLE WAS USED DURING A HYSTEROSCOPY, AS PART OF A FIBROID RESECTION USING GLYCINE. DURING THE PROCEDURE, THE CABLE BURNED AND DETACHED AT THE END CONNECTED TO THE HYSTEROSCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24445000 ↗
  • MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE INFORMATION RECEIVED, THE CABLE WAS BEING USED DURING A UROLOGICAL PROCEDURE. WHILE USING, THE CABLE SNAPPED AND A LOUD EXPLOSION WAS WITNESSED BY THE TEAM PRESENT INSIDE THE THEATRE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23884897 ↗
  • MalfunctionDec 19, 2025Sparking; Detachment of Device or Device Component; Sparking; Detachment of Device or Device Component

    THE FOLLOWING WAS REPORTED THE CORD BREAKS DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE COMPLAINT ID (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23854425 ↗
  • MalfunctionDec 16, 2025Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THE CORD BREAKS DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23816913 ↗
  • MalfunctionSep 4, 2025Break; Fire; Break; Fire

    IT WAS REPORTED THAT "THE MONOPOLAR CABLE WAS FOUND BROKEN AND ON FIRE DURING THE MONOPOLAR TURP CASE. THE MONOPOLAR CABLE WAS CONNECTED TO WOLF DIATHERMY AND THEIR 26R MONOPOLAR RESECTOSCOPE. A NEW 277KB WAS USED TO COMPLETE THE PROCEDURE AFTERWARDS". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22974287 ↗
  • MalfunctionJun 23, 2025Electrical Shorting; Excessive Heating; Electrical Shorting; Excessive Heating

    IT WAS REPORTED THAT MID CASE, ONE OF OUR TUR DIATHERMIES LEADS OVERHEATED AND SNAPPED OFF AT THE CONNECTION POINT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22311697 ↗
  • 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 MEDWATCH 9610617-2025-00782.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21961274 ↗
  • MalfunctionFeb 20, 2025Material Separation; Temperature Problem; Material Separation; Temperature Problem

    IT WAS REPORTED THAT A MONOPOLAR RESECTOSCOPE CABLE BURNT OUT DURING THE PROCEDURE. THE CUSTOMER HEARD A LOUD BAND AND NOTICED THE CABLE WAS SEVERED CLOSE TO THE RESECTOSCOPE. THE CUSTOMER HAD TO OPEN ANOTHER RESECTOSCOPE TRAY. NO PATIENT INVOLVEMENT. NO INFORMATION ON LENGTH OF SURGICAL DELAY OR PROLONGATION OF SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY OR HARM REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 21426841 ↗
  • MalfunctionJan 30, 2025Break; Sparking; Break; Sparking

    IT WAS REPORTED THAT WHEN USING THE MONOPOLAR RESECTOSCOPE, THE CUTTING FUNCTION WAS INTERMITTENTLY WORKING, THE COAGULATION FUNCTION WAS WORKING FINE. ON RE-ATTEMPT OF USING THE CUTTING FUNCTION THE DIATHERMY CABLE NEAR ITS CONNECTION TO THE RESECTOSCOPE SPARKED AND THE CABLE BROKE. THIS HAPPENED TOWARDS THE END OF THE PROCEDURE. THEREFORE, THE FIBROID HAD BEEN COMPLETELY RESECTED. THE PROCEDURE WAS STOPPED IMMEDIATELY AND THE RESECTOSCOPE WAS REMOVED. THE PATIENT DID NOT COME TO ANY HARM THANKFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21274629 ↗
  • MalfunctionDec 30, 2024Electrical /Electronic Property Problem; Sparking; Electrical /Electronic Property Problem; Sparking

    IT WAS REPORTED THAT DURING A RESECTION OF THE PROSTATE PROCEDURE ON (B)(6) 2024, THE CORD SPARKED WHEN THEY BEGAN TO RESECT. FIBERS ARE COMING OUT OF THE CORD WHERE IT CONNECTS IN TO THE GENERATOR. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP DEVICE WITHOUT ANY PATIENT HARM. HOWEVER, THE ISSUE CAUSED A DELAY OF THE CASE FOR ABOUT 15 MINUTES.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21036956 ↗
  • MalfunctionAug 22, 2024Material Separation; Sparking; Explosion; Material Separation; Sparking; Explosion

    IT WAS REPORTED THAT DURING THE PROCEDURE WHEN RESECTING THE PROSTATE THE DIATHERMY LEAD EXPLODED AND BROKE IN HALF. LEAD WAS DISCONNECTED AND TAKEN AWAY. NO HARM WAS CAUSED TO THE PATIENT OR STAFF MEMBERS.

    Patient problems: Insufficient Information

    MAUDE report 20036698 ↗
  • MalfunctionJul 8, 2024Sparking; Adverse Event Without Identified Device or Use Problem; Sparking; Adverse Event Without Identified Device or Use 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 19697786 ↗
  • MalfunctionJun 12, 2024Material Separation; Sparking; Insufficient Device Problem Information; Material Separation; Sparking; Insufficient Device Problem Information

    IT WAS REPORTED THAT A BROKEN LEAD BLEW UP DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19521816 ↗
  • MalfunctionNov 4, 2022Temperature Problem; Temperature Problem

    THE MANUFACTURES REFERENCE NUMBER (B)(4). DURING A RESECTION CASE ON (B)(6), THE CORD 277KB BLEW OFF WHERE IT ATTACHES TO THE RESECTOSCOPE DURING THE CASE AND CAUGHT THE DRAPES ON FIRE. PER OR MANAGER IN FOLLOW UP REPLY NOTED THAT THERE WAS NO FIRE INVOLVED, HOLE IN DRAPE. THE PATIENT WAS NOT HARMED AND WAS FOLLOWED UP IN RECOVERY. THE CORD WAS REPLACED AND THE PROCEDURE COMPLETED.

    Patient problems: Insufficient Information

    MAUDE report 15734579 ↗
  • MalfunctionAug 19, 2022Electrical /Electronic Property Problem; Flare or Flash; Electrical /Electronic Property Problem; Flare or Flash

    PER THE SALESREP DURING A BLADDER/PROSTATE RESECTION, WHEN ACTIVATING THE ESU FIRE/EXPLOSION OCCURRED AT THE INSTRUMENT AND WAS QUICKLY EXTINGUISHED. NO INJURY TO PATIENT OR TO STAFF REPORTED. THE CORD WAS REPLACED AND THE PROCEDURE COMPLETED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 15259949 ↗
  • MalfunctionDec 20, 2018Melted; Overheating of Device; Smoking

    THE LONG RESECTOSCOPE WAS BEING USED FOR BLADDER TUMOR RESECTION, WHEN THE SURGEON SMELLED SMOKE. SHE STOPPED OPERATING AND CHECKED EQUIPMENT. STATED THAT THE ELECTRICAL FELT WARM TO TOUCH AND APPEARED TO HAVE MELTED ON THE INSTRUMENT. PER SURGEON, SHE NOTICED A DECREASE IN THE AMOUNT OF POWER WHEN SHE WENT TO USE IT INITIALLY. THE SURGICAL TECH UNPLUGGED THE WORKING ELEMENT AND CORD AND THEN REATTACHED IT TO WHICH IT WAS THEN WORKING TO HER SATISFACTION. WHEN THEY STOPPED USING THE INSTRUMENT THEY NOTICED THAT THE PLACE WHERE THE COMPONENT ATTACHES TO EACH OTHER APPEARED THAT IT HAD MELTED. AT THAT POINT THE INSTRUMENTS WERE TAKEN OUT OF SERVICE FOR THE REMAINDER OF THE CASE. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8183939 ↗

Other ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices

All ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page