BEUDAMED
    FDA Adverse Event Summary report: N

    OPERON

    MDR report key: 1843591 · Received September 23, 2010

    Report

    Report Number
    1220685-2010-00002
    Date Received
    September 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FWY
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SHOWED THAT THE CASTING FOR THE LEG SECTION CONNECTOR WAS DAMAGED. THIS PART WAS BENT BEYOND ITS SPECIFICATION AND DID NOT ALLOW THE LEG SECTION TO PROPERLY CONNECT TO THE TABLE. THIS DAMAGED CONNECTOR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE USER HAD A SHOULDER CHAIR ACCESSORY ASSEMBLED TO THE LEG SECTION OF AN OPERON B 810 TABLE. DURING THE CASE, THE LEG SECTION CAME DETACHED FROM THE TABLE AND PARTIALLY FELL. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON SURGICAL TABLE FWY BERCHTOLD CORP B 810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other