BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM

    MDR report key: 1396483 · Received April 7, 2009

    Report

    Report Number
    3005075853-2009-02120
    Event Type
    Malfunction
    Date Received
    April 7, 2009
    Date of Event
    February 24, 2009
    Report Date
    March 13, 2009
    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

    EVAL SUMMARY: THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE MULTIPLE CLIP APPLIER WAS VISUALLY AND FUNCTIONALLY EVALUATED AND NO ANOMALIES WERE NOTED; IT FED AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING REQUIREMENTS WHEN TESTED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIEP FLAP PROCEDURE, THE CLIPS WERE CUTTING THE VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1