BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 4148530 · Received October 2, 2014

    Report

    Report Number
    MW5038476
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    January 16, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SONICISION DEVICE WAS NOT WORKING. THEY THOUGHT THEY SAW A METAL SHARD IN THE ABDOMEN. PER OP REPORT: A LITTLE CHIP OF LESS THAN 1 MM WAS NOTED WITHIN THE JAWS OF THE SONICISION DEVICE AT ONE POINT DURING ATTEMPT TO USE THE SONICISION DEVICE. THE FIRST SONICISION DEVICE ALSO DID NOT WORK. THE DEVICE WAS SENT TO THE MANUFACTURER AND FOUND TO HAVE BEEN INTACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615307 COVIDIEN PURSTRING DEVICE LFL COVIDIEN 236010X

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR