BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM

    MDR report key: 1112546 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01100
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 17, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ON AN UNKNOWN FIRING, THE CLIP DID NOT FORM PROPERLY. THE SAME DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM GDO ETHICON ENDO-SURGERY, LLC NA E4KZ7D

    Patients

    Seq Age Sex Outcome Treatment
    1