BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5031084

    MDR report key: 5031084 · Received August 26, 2015

    Report

    Report Number
    5031084
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 18, 2015
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE DEVICE AND IT FAILED. IT DID NOT ADVANCE PROPERLY TO CUT THE TISSUE.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR