BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 7236487 · Received February 2, 2018

    Report

    Report Number
    1825014-2018-00001
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 30, 2018
    Manufacturer
    IHB OPERATIONS B.V.
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SERVICING AND INSTALLING OF REPLACEMENT COMPONENTS ON A SKYTRON DUAL, AFS SERIES SURGICAL DISPLAY MONITOR ARM REQUIRES THE REMOVAL OF SURGICAL DISPLAYS AND REMOVAL OF THE EXTERIOR COVERS AND ASSOCIATED HARDWARE TO PROVIDE ACCESS TO THE VERTICAL SUPPORT TUBE, MOUNTING DISC AND THREADED ROD. THE TECHNICIAN COMPLETED THE END BEARING SIDE REPLACEMENT TO THE AFS AND INSTALLED THE PARALLEL ROD AND LINK BRACKET. THIS IS PROCEEDED BY THE INSTALLATION OF THE NEW CLAMP BLOCKS FOR THE PARALLEL ROD ON THE MAIN BEARING SIDE. THE TECHNICIAN PLACED THE CLAMP BLOCK IN PLACE WITH TWO BOLTS AND PROCEEDED TO DRILL AND TAP TWO NEW THREADED M6 HOLES IN THE BEARING BUSHING. AFTER COMPLETING THIS STEP THE TECHNICIAN TRIED TO ALIGN THE CLAMP BLOCK, PARALLEL ROD AND ADJUSTMENT CAM ASSEMBLY INTO PLACE. THE TECHNICIAN THEN NOTICED THAT THE AFS SPRING ARM HAD JAMMED THE CLAMP BLOCK AGAINST THE BEARING BUS. USING HIS LEFT ARM THE TECHNICIAN PULLED DOWN ON THE AFS TRYING TO RELIEVE TENSION ON THE ARM SO HE COULD FEEL THE CLAMP BLOCK LOOSEN ENOUGH SO HE COULD ALIGN IT INTO PLACE SO HE COULD APPLY THE FINAL SCREWS. THE TECHNICIAN'S FINGER GOT CAUGHT IN THE SPRING ARM RESULTING IN AN INJURY TO HIS FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81370 SKYTRON BOOM FQO IHB OPERATIONS B.V. 2E/AFS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other