BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2032198 · Received March 29, 2011

    Report

    Report Number
    3005075853-2011-01234
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 3, 2011
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPS CROSSED AND SCISSORED WHEN THE DEVICE HAD BEEN FIRED MULTIPLE TIMES . THEY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS LEFT IN THE MATERIALS DEPARTMENT WITH A NOTE AND NO ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1