BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERCHTOLD OPERON D860

    MDR report key: 8749802 · Received July 1, 2019

    Report

    Report Number
    MW5087728
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 19, 2019
    Manufacturer
    STRYKER COMMUNICATIONS INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    WHEN THE LEG SPARS ON THE TABLE ARE NOT PRECISELY ALIGNED, PRESSING THE UP OR DOWN LEG BUTTON ON THE HAND PENDANT CAUSES THE LEG SPARS TO CONTINUE MOVING UP OR DOWN ON THEIR OWN AFTER THE BUTTON IS RELEASED. THIS INCLUDES A FULL UPWARD FLEXION OF THE LEG SPARS WHEN THE CABLE IS SUPINE. THE LEG SPARS WILL CONTINUE MOVING THROUGH THEIR FULL RANGE OF MOTION AND CAN ONLY BE STOPPED BY TURNING OFF POWER TO THE TABLE. THESE UNINTENDED MOVEMENTS PLACE PTS AT RISK FOR SERIOUS INJURY. ACCORDINGLY, ALL SIX TABLES HAVE BEEN TAKEN OUT OF USE. REF MW5087729, MW5087730, MW5087731, MW5087732, MW5087733.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542477 BERCHTOLD OPERON D860 TABLE, OPERATING ROOM, ELECTRICAL GDC STRYKER COMMUNICATIONS INC. D 860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention