CLICKLINE 33300MRecalls & reported problems
Karl Storz GmbH & Co. KG · CLICKLINE Metal Outer Sheath · Class 2
All models of CLICKLINE (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551133965), received between Jan 29, 2025 and Dec 16, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
- Detachment of Device or Device Component5
- Break3
- Mechanical Problem2
- Material Fragmentation1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Material Separation; Material Separation
IT WAS REPORTED THAT INSERT-SIDE CONNECTION OF THE DISTAL TIP CAME OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE DETACHED PART DID NOT FALL INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821208 ↗MalfunctionNov 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DETACHMENT OF THE NOTCHED TIP COMPONENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498696 ↗MalfunctionSep 9, 2025Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE SHEATH FELL OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011407 ↗MalfunctionSep 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE SHEATH FELL OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23011406 ↗MalfunctionAug 13, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE SHEATH FEIL OFF. THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797213 ↗MalfunctionJan 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE OUTER SHEATH COMES OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21274743 ↗MalfunctionJan 29, 2025Material Fragmentation; Mechanical Problem; Material Integrity Problem; Material Fragmentation; Mechanical Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CLICKLINE METAL OUTER SHEATH TUBES ARE VERY RIGID WHICH HAVE CAUSED BREAKAGE BELOW THE JOINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21265993 ↗
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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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