BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOSTAR MODULARIS

    MDR report key: 589674 · Received April 8, 2005

    Report

    Report Number
    2240869-2005-00004
    Event Type
    Injury
    Date Received
    April 8, 2005
    Date of Event
    October 11, 2004
    Report Date
    February 4, 2005
    Manufacturer
    SIEMENS AG
    Product Code
    MMZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, A PT USED THE FRAME OF THE EXAMINATION TABLE AS A HAND GRIP. WHEN THE EXAMINATION TABLE WAS MOVED BY THE OPERATOR, THE PT'S FINGERS WERE REPORTEDLY INJURED, RESULTING IN TWO BROKEN FINGERS. THE USER'S MANUAL CLEARLY WARNS AGAINST POSSIBLE DANGER POINTS AND STATES THAT NO PART OF THE PT'S BODY MAY PROJECT BEYOND THE TABLETOP DURING AN EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITHOSTAR MODULARIS UROLOGICAL TABLE MMZ SIEMENS AG 5531012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other