BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICISION

    MDR report key: 2982166 · Received February 25, 2013

    Report

    Report Number
    2982166
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS WORKING UNTIL A RED LIGHT APPEARED. THE BATTERY WAS CHANGED, BUT THE PRODUCT STILL FAILED TO CUT OR COAGULATE TISSUE. THE DEVICE WAS TAKEN OUT OF SERVICE AND REPLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78996 SONICISION INSTRUMENT, ULTRASONIC, SURGICAL LFL COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE SCD396 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR