BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2020247 · Received March 16, 2011

    Report

    Report Number
    3005075853-2011-01044
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    November 2, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE FIRED THROUGH LOCKOUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TRIGGER WOULD NOT DEPLOY THE CLIPS. A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED. NO OTHER DETAILS OF THE EVENT ARE KNOWN.

    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