BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D850

    MDR report key: 2820961 · Received October 29, 2012

    Report

    Report Number
    MW5027454
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    June 21, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BERCHTABLE
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BERCHTOLD OPERON D850 UNINTENTIONAL MOTION. TABLE TILTED LEFT DURING ROBOTIC SURGERY. NO PT INJURY. TABLE HAND CONTROL WAS ON FLOOR AT THE TIME OF UNINTENTIONAL TILT MOTION. HOSPITAL¿S BIOMEDICAL ENGINEERING DEPT COULD NOT DUPLICATE PROBLEM. TABLE WAS TESTED BY BERCHTOLD FIELD SERVICE ENGINEER AND NO PROBLEMS WERE IDENTIFIED. TABLE HAND CONTROL FROM THIS TABLE WAS REMOVED BY BERCHTOLD AND RETURNED TO (B)(4) FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON D850 SURGICAL TABLE GDC BERCHTABLE D850

    Patients

    Seq Age Sex Outcome Treatment
    1