BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO

    MDR report key: 747034 · Received October 14, 2005

    Report

    Report Number
    MW1036926
    Event Type
    Malfunction
    Date Received
    October 14, 2005
    Date of Event
    October 12, 2005
    Report Date
    October 14, 2005
    Manufacturer
    BOSTON SCIENTIFIC, MIAMI TECHNOLOGY CTR
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CAPIO DEVICE NUMBER 831125 JAMMED AND DID NOT PASS ARROW HEAD, WITH LOADED SUTURE, PROPERLY. ARROW HEAD RETAINED IN PT. SURGEON FELT DEVICE WAS FAULTY. DEVICE WAS OPENED BY SURGEON TO SEARCH FOR ARROW HEAD. NOT FOUND. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE CAPTURING DEVICE MFJ BOSTON SCIENTIFIC, MIAMI TECHNOLOGY CTR 831125 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *