BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1190782 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02165
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 12, 2008
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/07/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE DEVICE WAS FIRED ACROSS THE CYSTIC ARTERY. THE DEVICE FIRED TWO CLIPS AND WOULD NOT OPEN. THE SURGEON TRIED PULLING THE HANDLES MANUALLY AND IT STILL WOULD NOT OPEN. GRASPERS WERE USED TO PRY THE JAWS OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1