CLICKLINE 30310MLSRecalls & reported problems
Karl Storz GmbH & Co. KG · CLICKLINE Outer Sheath/Forceps Insert · Class 2
All models of CLICKLINE (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551121818), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Burn, Thermal1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
ALLEGEDLY, PER THE CUSTOMER, CURRENT LEAKED THROUGH THE INSULATION OF THE INSTRUMENT AND BURNED THE INFANT ON THE RIGHT ABDOMEN. THE FACILITY HAS NOT PROVIDED ANY DETAILS OF THE INCIDENT, THEREFORE; WE HAVE NO INFORMATION REGARDING THE EVENT OR THE PATIENT.
Patient problems: Burn, Thermal
MAUDE report 10459096 ↗
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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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