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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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