BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMACLIP REUSABLE HD1. W/DISP.CLIP CARTRIDGE

    MDR report key: 973854 · Received January 4, 2008

    Report

    Report Number
    1320894-2008-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2008
    Date of Event
    October 1, 2007
    Report Date
    January 4, 2008
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IN ANTICIPATED, BUT AS YET HAS NOT BEGUN. WE WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETED. NOTE: THE HANDLE TO THIS DEVICE IS REUSABLE THE CARTRIDGE INSTALLED IN DEVICE BEFORE SHIPPING IS DISPOSABLE. THIS DEVICE IS MANUFACTURED FOR CONMED. THE DEVICE HAS BEEN RETURNED TO CONMED, AND WILL BE SENT TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER 5 SHOTS, CLIPS STOP GOING OUT, AND CLIPS DIDN'T GRIPPED ENOUGH OVER THE ARTERIES AND FELL DOWN INTO THE PT EVEN THOUGH THEY LOOKED WELL CLOSED. CLIPS HAVE BEEN TWISTED WHEN CLICKED OVER THE ARTERIES AND THEN FELL DOWN INTO PT. NO PT INJURY, HOWEVER, SURGERY TIME WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACLIP REUSABLE HD1. W/DISP.CLIP CARTRIDGE LAPAROSCOPIC CLIP APPLIER GDO DESIGN STANDARDS CORP NA 0408-052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR