BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON

    MDR report key: 2710960 · Received August 15, 2012

    Report

    Report Number
    8010153-2012-00004
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Date of Event
    July 9, 2012
    Report Date
    August 3, 2012
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REP ON (B)(4) 2012. THE PROBLEM WAS NOT DUPLICATED. THE HAND CONTROL HAD SOME DAMAGE, AND THE HEIGHT SENSOR REQUIRED REPLACEMENT, BUT NEITHER OF THESE COULD BE DIRECTLY LINKED TO THE MALFUNCTION. BOTH THE HEIGHT SENSOR AND THE HAND CONTROL WERE REPLACED AND THE TABLE WAS PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WITH A PT ON THE TABLE, AND UTILIZING A DAVINCI ROBOT, THE TABLE WAS REPORTED TO HAVE MOVED FROM A TRENDELENBURG POSITION TO A LEVEL POSITION WITHOUT ANY ACTIVATION OF THE LEVEL BUTTON ON THE HAND CONTROL. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON SURGICAL TABLE FWY BERCHTOLD GMBH & CO. KG D820

    Patients

    Seq Age Sex Outcome Treatment
    1