BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1930143 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07195
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MISFIRED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO ADVERSE CONSEQUENCES REPORTED. NO DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4P4T4

    Patients

    Seq Age Sex Outcome Treatment
    1