BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1831658 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05461
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    August 7, 2007
    Report Date
    August 7, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY, THE DEVICE STAYED LOCKED WHEN THE TRIGGER WAS SQUEEZED. THEY WERE ABLE TO GET IT OFF THE TISSUE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HK6V

    Patients

    Seq Age Sex Outcome Treatment
    1