BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON SURGICAL TABLE

    MDR report key: 4144575 · Received September 23, 2014

    Report

    Report Number
    8010153-2014-00037
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL INVESTIGATION, IT WAS DISCOVERED THAT THE STAFF INFORMED THE INITIAL REPORTER THAT THE TABLE HAD BEEN LOWERED ONTO A MAYO STAND THAT WAS POSITIONED UNDER THE LEG SECTION CAUSING THE TABLE TO DROP SUDDENLY WHEN THE STAND SLID AWAY FROM THE TABLE. THERE WAS NO REPORTED ISSUE WITH THE TABLE ITSELF, BUT THE EVEN TWAS CAUSED BY USER ERROR DUE TO FAILING TO ENSURE OBJECTS WERE AWAY FROM THE TABLE DURING THE DOWNWARD MOVEMENT. THE CUSTOMER RETURNED THE TABLE BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGICAL TABLE WAS IN THE PROCESS OF DOWNWARD MOTION WHEN THE TABLE SUDDENLY DROPPED APPROXIMATELY 24 INCHES. THERE WAS NO REPORTED INJURY OT A PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591079 OPERON SURGICAL TABLE TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG D820

    Patients

    Seq Age Sex Outcome Treatment
    1