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CLICKLINE 34310MA-DRecalls & reported problems

Karl Storz GmbH & Co. KG · CLICKLINE Scissors Insert · Class 2

All models of CLICKLINE (46)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551336434), received between Sep 20, 2019 and Jun 11, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).

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: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Arcing of Electrodes1
  • Material Separation1
  • Melted1
  • Thermal Decomposition of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Burn, Thermal1
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 11, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

    ACCORDING TO THE INFORMATION AVAILABLE, THE INSULATION ON THE SHAFT OF THE DISPOSABLE SCISSORS WAS CHARRED DURING SURGERY. NO NEGATIVE EFFECTS ON THE PROCEDURE, THE PATIENT, THE USER, OR THIRD PARTIES HAVE BEEN REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22185967 ↗
  • InjuryAug 17, 2022Material Separation; Material Separation

    AS PER A MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN GERMANY: THE EVENT OCCURRED IN SWITZERLAND. DURING A DIAGNOSTIC LAPAROSCOPY, THE INSULATION RING OF THE CLICKLINE SCISSORS INSERT CAME LOOSE AND FELL INTO THE ABDOMEN, WHICH CAUSED A DELAY IN THE SURGERY FOR 80 MINS, AND THE ABDOMEN NEEDED TO BE OPENED BY LAPAROTOMY TO SEARCH AND SALVAGE THE LOOSENED PART.

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

    MAUDE report 15242929 ↗
  • MalfunctionSep 20, 2019Arcing of Electrodes; Arcing of Electrodes

    ALLEGEDLY, DURING A LAPAROSCOPIC EXCISION AND FULGURATION OF ENDOMETRIOSIS PROCEDURE, TOWARD THE END OF THE PROCEDURE, THE DOCTOR "ZAPPED A BLEEDER TO CAUTERIZE" . WHEN THE DOCTOR PULLED THE INSTRUMENT AWAY THE BURNS WERE NOTICED. THE PROCEDURE WAS COMPLETED, NO OTHER INTERVENTION WAS REQUIRED .

    Patient problems: Burn, Thermal

    MAUDE report 9100427 ↗

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Sources and updates

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