CLICKLINE 30310ULSRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551121924), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Optical Obstruction1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY; SURGEON SAW A BLACK OBJECT ADHERER INTERNALLY IN THE PATIENT WHICH WAS RETAINED FROM A PREVIOUS SURGERY. SCAR TISSUE HAD BEGUN TO FORM AROUND IT. THE OBJECT WAS REMOVED. STAFF AND SURGEON DETERMINED IT WAS A SHAVING FROM THE OUTER SHEATH OF THE CLICKLINE INSTRUMENT AND LIKELY CAUSED BY DRAGGING IN OR OUT OF TROCAR CANNULA. BOTH KS AND DISPOSABLE TROCARS WERE USED. PICTURES ATTACHED. THE HOSPITAL IS REPORTING IT AS A SENTINEL EVENT. OTHER THAN SCAR TISSUE FORMATION, PATIENT WAS UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906071 ↗InjuryAug 27, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY; SURGEON SAW A BLACK OBJECT ADHERER INTERNALLY IN THE PATIENT WHICH WAS RETAINED FROM A PREVIOUS SURGERY. SCAR TISSUE HAD BEGUN TO FORM AROUND IT. THE OBJECT WAS REMOVED. STAFF AND SURGEON DETERMINED IT WAS A SHAVING FROM THE OUTER SHEATH OF THE CLICKLINE INSTRUMENT AND LIKELY CAUSED BY DRAGGING IN OR OUT OF TROCAR CANNULA. BOTH KS AND DISPOSABLE TROCARS WERE USED. PICTURES ATTACHED. THE HOSPITAL IS REPORTING IT AS A SENTINEL EVENT. OTHER THAN SCAR TISSUE FORMATION, PATIENT WAS UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906067 ↗
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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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