CLICKLINE 34310MA-DRecalls & reported problems
Karl Storz GmbH & Co. KG · CLICKLINE Scissors Insert · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551336434), received between Sep 20, 2019 and Jun 11, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Arcing of Electrodes” (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
- Arcing of Electrodes1
- Material Separation1
- Melted1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn, Thermal1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted
ACCORDING TO THE INFORMATION AVAILABLE, THE INSULATION ON THE SHAFT OF THE DISPOSABLE SCISSORS WAS CHARRED DURING SURGERY. NO NEGATIVE EFFECTS ON THE PROCEDURE, THE PATIENT, THE USER, OR THIRD PARTIES HAVE BEEN REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185967 ↗InjuryAug 17, 2022Material Separation; Material Separation
AS PER A MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN GERMANY: THE EVENT OCCURRED IN SWITZERLAND. DURING A DIAGNOSTIC LAPAROSCOPY, THE INSULATION RING OF THE CLICKLINE SCISSORS INSERT CAME LOOSE AND FELL INTO THE ABDOMEN, WHICH CAUSED A DELAY IN THE SURGERY FOR 80 MINS, AND THE ABDOMEN NEEDED TO BE OPENED BY LAPAROTOMY TO SEARCH AND SALVAGE THE LOOSENED PART.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15242929 ↗MalfunctionSep 20, 2019Arcing of Electrodes; Arcing of Electrodes
ALLEGEDLY, DURING A LAPAROSCOPIC EXCISION AND FULGURATION OF ENDOMETRIOSIS PROCEDURE, TOWARD THE END OF THE PROCEDURE, THE DOCTOR "ZAPPED A BLEEDER TO CAUTERIZE" . WHEN THE DOCTOR PULLED THE INSTRUMENT AWAY THE BURNS WERE NOTICED. THE PROCEDURE WAS COMPLETED, NO OTHER INTERVENTION WAS REQUIRED .
Patient problems: Burn, Thermal
MAUDE report 9100427 ↗
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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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