BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8CM, 20 MEDIUM

    MDR report key: 1160585 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01646
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE DEVICE CUT THE TISSUE INSTEAD OF CLIPPING IT. USED SUTURES TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8CM, 20 MEDIUM GDO ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1