BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSONIX

    MDR report key: 2913384 · Received December 14, 2012

    Report

    Report Number
    2913384
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 28, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COVIDIEN , INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    TIP OF AUTOSONIX HOOK PROBE BROKE OFF IN PATIENT. TIP WAS RETRIEVED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSONIX ULTRASONIC COAGULATION PROBE LFL COVIDIEN , INC * N2E0031X

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR