BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPERON

    MDR report key: 535353 · Received March 15, 2004

    Report

    Report Number
    1220685-2004-00002
    Event Type
    Other
    Date Received
    March 15, 2004
    Date of Event
    February 13, 2004
    Report Date
    March 10, 2004
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CASE, AMATECH'S "SHOULDER BEACH CHAIR", PART NUMBER F-SCBER, WAS ASSEMBLED TO THE SURGICAL TABLE INORDER TO SUPPORT A PATIENT'S BACK. THIS ACCESSORY MOUNTS TO THE MEDICAL RAILS ON THE DETACHABLE LEG SECTION OF THE SURGICAL TABLE, WHILE BEING USED, THE LEG SECTION CAME DETACHED FROM THE SURGICAL TABLE CAUSING THE PT'S BACK TO BECOME UNSUPPORTED. NO PT INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    THERE HAVE NOT FURTHER COMPLAINTS REGARDING THE LEG SECTION BEING DETACHED WHILE USING AMATECH'S "SHOULDER BEACH CHAIR", PART NUMBER F-SCBER. SINCE THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT OCCURRED DUE TO USER ERROR AND THERE HAS ONLY BEEN ONE OCCURENCE, NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS HAVE BEEN TAKEN. NO DESIGN CHANGES HAVE BEEN IMPLEMENTED. THE CORRECT USE OF THE PRODUCT IS DESCRIBED IN THE USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON SURGICAL TABLE FQO BERCHTOLD CORP. B810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other