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CLICKLINE 33126Recalls & reported problems

Karl Storz GmbH & Co. KG · CLICKLINE Plastic Handle · Class 2

All models of CLICKLINE (46)

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

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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551125113), received between Jan 17, 2025 and Jan 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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: 2 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 2 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break4
  • Detachment of Device or Device Component1
  • Device Reprocessing Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Insufficient Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 12, 2026Break

    IT WAS REPORTED THAT THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00022.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24039347 ↗
  • MalfunctionJan 12, 2026Break

    IT WAS REPORTED THAT THE CAUTERY POST BROKE WHEN THE CAUTERY CORD WAS ATTACHED TO THE HANDLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00020.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24039336 ↗
  • MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE DEVICE BROKE PRIOR TO USE, PROXIMAL END OF SHEATH SNAPPED INSIDE HANDLE. NO PATIENT INVOLVEMENT. BROKEN DURING SET UP FOR PROCEDURE, 2-MINUTE DELAY TO PROCEDURE. NEW SET WAS USED, AND PROCEDURES CONTINUED. SINCE NO PATIENT INVOLVEMENT AND NO INJURY TO PATIENT. CROSS REFERENCE MDR: 9610617-2025-00373.

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

    MAUDE report 21531718 ↗
  • MalfunctionJan 17, 2025Break; Break

    IT WAS REPORTED THAT THE HANDLES OF THE PRODUCT BROKE AND SNAPPED AWAY THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. NEW INFORMATION WAS PROVIDED THAT THE ISSUE OCCURRED DURING USE. IT WAS REPORTED THAT THE CLICKLINE HANDLE BROKE DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21180389 ↗
  • MalfunctionJan 17, 2025Break; Device Reprocessing Problem; Break; Device Reprocessing Problem

    IT WAS REPORTED THAT THE HANDLES OF THE PRODUCT BROKE AND SNAPPED AWAY THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. NEW INFORMATION WAS PROVIDED THAT THE ISSUE OCCURRED DURING USE. IT WAS REPORTED THAT THE CLICKLINE HANDLE BROKE DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21180388 ↗

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Sources and updates

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