CLICKLINE 31300Recalls & reported problems
Karl Storz GmbH & Co. KG · CLICKLINE Outer Sheath · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551333921), received between Jun 18, 2025 and Jun 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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
- Electrical /Electronic Property Problem3
- Detachment of Device or Device Component2
- Material Split, Cut or Torn2
- Image Display Error/Artifact1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Electrical /Electronic Property Problem; Detachment of Device or Device Component; Material Split, Cut or Torn; Electrical /Electronic Property Problem; Detachment of Device or Device Component; Material Split, Cut or Torn
IT HAS BEEN REPORTED DURING RECENT INSULATION TESTING, IDENTIFIED ARCING IN CERTAIN AREAS OF THE SHEATHING FOR THE MINI LAPAROSCOPIC INSTRUMENTS. INTERESTINGLY, THE ARCING OCCURRED IN THE SAME AREA ACROSS DIFFERENT SHEATHS WITHIN THE SAME TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283499 ↗MalfunctionJun 18, 2025Electrical /Electronic Property Problem; Detachment of Device or Device Component; Material Split, Cut or Torn; Electrical /Electronic Property Problem; Detachment of Device or Device Component; Material Split, Cut or Torn
IT HAS BEEN REPORTED DURING RECENT INSULATION TESTING, IDENTIFIED ARCING IN CERTAIN AREAS OF THE SHEATHING FOR THE MINI LAPAROSCOPIC INSTRUMENTS. INTERESTINGLY, THE ARCING OCCURRED IN THE SAME AREA ACROSS DIFFERENT SHEATHS WITHIN THE SAME TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283396 ↗MalfunctionJun 18, 2025Electrical /Electronic Property Problem; Image Display Error/Artifact; Electrical /Electronic Property Problem; Image Display Error/Artifact
IT HAS BEEN REPORTED DURING RECENT INSULATION TESTING, IDENTIFIED ARCING IN CERTAIN AREAS OF THE SHEATHING FOR THE MINI LAPAROSCOPIC INSTRUMENTS. INTERESTINGLY, THE ARCING OCCURRED IN THE SAME AREA ACROSS DIFFERENT SHEATHS WITHIN THE SAME TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283379 ↗
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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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