BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 643692 · Received September 30, 2005

    Report

    Report Number
    1527736-2005-04551
    Event Type
    Malfunction
    Date Received
    September 30, 2005
    Date of Event
    September 28, 2005
    Report Date
    September 29, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE DOCTOR FIRED THE INSTRUMENT, IF HE SQUEEZED THE HANDLE TOO HARD, THE CLIP SCISSORED ON HIM, AND IF HE TRIED NOT SQUEEZING THE HANDLE AS HARD TO PREVENT SCISSORING, THE CLIP WOULD NOT HOLD ON CYSTIC DUCT. CASE COMPLETED WITH SAME INSTRUMENT. NO PT CONSEQUENCES. NO INSTRUMENT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC MULTIPLE CLIP APPLIER GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN