BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5-POLE SPRING ARM AC 2000 15-21 KG

    MDR report key: 1614428 · Received February 2, 2010

    Report

    Report Number
    2031963-2010-00036
    Event Type
    Injury
    Date Received
    February 2, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE IS UNK AT THIS POINT IN TIME. FURTHER ATTEMPTS WILL BE MADE FOR THIS INFO. EVAL SUMMARY: THE INVESTIGATION DETERMINED THAT THE CIRCLIP HOLDING SPRING ARM WAS INSTALLED INCORRECTLY WHICH ALLOWED THE HORIZONTAL ARM TO FALL. THE CIRCLIP (0682-000-223) IS A COMPONENT OF THE EDS SUSPENSION THAT HOLDS THE SPRING ARM/LIGHT ASSEMBLY TO THE EXTENSION/HORIZONTAL ARM. THE CIRCLIP IS INSTALLED BY USING A SPECIFIC TOOL TO PLACE THE CIRCLIP IN ITS INTENDED POSITION. IF THE CIRCLIP IS NOT INSTALLED PROPERLY, THIS CAN LEAD TO A LIGHT HEAD/SPRING ARM ASSEMBLY FALLING. THIS FAILURE POSES A SEVERE HEALTH RISK BECAUSE, IF THE CIRCLIP IS NOT INSTALLED PROPERLY, THEN THE LIGHT HEAD/SPRING ARM ASSEMBLY CAN FALL AND POSSIBLY LEAD TO ADVERSE CONSEQUENCES. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS POSITIONING THE SURGICAL LIGHTS FOR HIS UPCOMING CASE WHEN THE SPRING ARM AND LED LIGHT HEAD FELL FROM LIGHT SUSPENSION'S HORIZONTAL ARM, LANDING ON SURGICAL RESIDENT'S SHOULDER HITTING HIM ON THE SHOULDER AND LIP THEN FALLING DIRECTLY ON THE SURGICAL TABLE. THE LIGHT HEAD WAS STILL CONNECTED TO THE SPRING ARM WHEN IT DETACHED FROM THE HORIZONTAL ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5-POLE SPRING ARM AC 2000 15-21 KG FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR