BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE

    MDR report key: 1880588 · Received October 5, 2010

    Report

    Report Number
    1880588
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 5, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE DIRECT DRIVE CLIP APPLIER FOR THE SCHEDULED LAPAROSCOPIC CHOLECYSTECTOMY AND REALIZED IT WAS NOT WORKING PROPERLY. WHEN THEY REMOVED THE INSTRUMENT FROM THE PATIENT, THEY FOUND THAT A PIECE OF THE TIP HAD BROKEN OFF IN THE PATIENT. THEY WERE ABLE TO RETRIEVE THE ENTIRE PIECE WITHOUT DIFFICULTY AND THE CASE WAS COMPLETED WITH A NEW REPLACEMENT DEVICE.THE MANUFACTURER HAS PICKED UP THE EQUIPMENT AND TAKEN IT BACK TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE CLIP APPLIER, LAPAROSCOPIC FZP APPLIED MEDICAL RESOURCES CORP. CA090 119565

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NO OTHER THERAPIES