BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 4110852 · Received September 23, 2014

    Report

    Report Number
    3005075853-2014-06621
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE SURGEON COMPLAINED ABOUT THE CLOSURE SYSTEM OF THE CLIPS. IT SEEMS THAT WHEN THE CLIP CLOSES THE LEGS STAY IN A CROSSED POSITION. THEREFORE, THE CLAMPING FUNCTION IS COMPROMISED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590562 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EN9R

    Patients

    Seq Age Sex Outcome Treatment
    1