BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 867782 · Received September 29, 2006

    Report

    Report Number
    3019090-2006-00003
    Event Type
    Other
    Date Received
    September 29, 2006
    Report Date
    August 29, 2006
    Manufacturer
    GETINGE USA, INC (F.K.A MDT DIAGNOSTIC CO)
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPENSION SYSTEM WAS NOT CORRECTLY INSTALLED BECAUSE THE ROLL PIN WAS NOT INSTALLED. IT APPEARS THAT OVER 14 YEARS OF USE, THE MAIN ARM EVENTUALLY BECAME UNSCREWED FROM THE SUSPENSION TUBE AND DETACHED. THIS SCENARIO CAN HAPPEN IF THE SYSTEM IS NOT PROPERLY INSTALLED. CUSTOMER HAS POSSESSION OF THE UNIT WHICH REMAINS OUT OF SERVICE.

    Description of Event or Problem · 1

    THE ATTACHMENT SPINDLE WHICH THREADS INTO SUSPENSION TUBE BACKED OUT THE TUBE ALLOWING THE LAMP HEAD TO FALL FROM CEILING HITTING PATIENT AND SURGEON. SURGEON WAS PRELIMINARILY EVALUATED FOR POSSIBLE CONCUSSION/HEAD TRAUMA, THE PATIENT FOR SOFT TISSUE INJURY TO ABDOMEN AND BILATERAL LOWER EXTREMITIES. FACILITY REFUSED TO PROVIDE ADDITIONAL INFORMATION TO MAINTAIN CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE SURGICAL LAMP FSY GETINGE USA, INC (F.K.A MDT DIAGNOSTIC CO) 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR