BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD OPERON

    MDR report key: 3932402 · Received April 2, 2014

    Report

    Report Number
    8010153-2013-00022
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEG SECTION DETACHED FROM THE TABLE DURING A SURGICAL PROCEDURE. DURING THIS PROCEDURE, A SMITH & NEPHEW SPIDER 2 LIMB POSITIONER WAS ATTACHED TO THE LEG SECTION. SUBSEQUENT INVESTIGATION BY BERCHTOLD FIELD SERVICE COULD NOT FIND AND DAMAGE OR INDICATION OF A FAILURE WITH THE OPERON LEG SECTION OR THE ATTACHMENT MECHANISM TO THE TABLE. THIS FACILITY HAS BEEN USING THE SMITH & NEPHEW SPIDER 2 LIMB POSITIONER WITH THE OPERON D850 TABLE WITH NO PROBLEMS UNTIL THIS RECENT INCIDENT. BERCHTOLD HAS NOT YET TESTED THE SMITH & NEPHEW SPIDER 2 LIMB POSITIONER WITH THE OPERON D850 TABLE, THUS COULD NOT PROVIDE ANY DETAILED ANALYSIS. BERCHTOLD RECOMMENDED THAT THE OPERON SECTIONS TO WHICH THE SPIDER 2 IS ATTACHED ARE SOLIDLY LOCKED TO THE TABLE PRIOR TO USE, AND TO PERIODICALLY CHECK THEM DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200006 BERCHTOLD OPERON (GDC) TABLE, OPERATING ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG D850

    Patients

    Seq Age Sex Outcome Treatment
    1