BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON PRECISION HD CAMERA ONLY FOR AUT & AUA SERIES

    MDR report key: 12066522 · Received June 25, 2021

    Report

    Report Number
    1825014-2021-00015
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 25, 2021
    Manufacturer
    DKK DAI-ICHI SHOMEI CO, LTD
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SKYTRON RECEIVED A COMPLAINT (B)(4) ON JUNE 3, 2021, ALLEGING THAT "SHORTLY AFTER A CASE FINISHED ONE OF THE SCRUB TECHS NOTICED A TINY SCREW DROP INTO THE SURGICAL FIELD..ON THE FRONT OF THE CAMERA ONE OF THE FOUR PHILIPS HEAD SCREWS HAD DROPPED OUT OF THE FRONT OF THE CAMERA." SKYTRON RECEIVED THE FOLLOWING RESPONSE FROM THE CUSTOMER DURING OUR INVESTIGATION, "PLEASE SEE OUR ANSWERS BELOW. THAT IS ALL THE INFORMATION WE OR SPECTRUM CAN PROVIDE. SO PLEASE CLOSE ON OUR END. WE CAN NOT ISOLATE THAT SERIAL #. THANKS! THE CAMERA IS ONLY USED WHEN THEY WANT TO USE IT. IF NOT, IT IS STORED AND THE HANDLE ADAPTER IS USED WITH THE DEVON HANDLE. WHEN THE CAMERA IS USED THEY ALWAYS USE A CAMERA COVER! NO ON THE FACILITY ADJUSTING THEM. SCREW WAS REINSTALLED BY CUSTOMER." THE PROBABILITY OF OCCURENCE OF THIS ISSUE IS EXTREMELY LOW. SKYTRON WILL CONTINUE TO MONITOR FOR TRENDS OF THIS ISSUE AND IS CLOSING THIS FILE. THE RESPONSE BELOW WAS PROVIDED BY THE MANUFACTURER, DKK: WHEN INSTALLING THE SCREW, A SPRING IS USED INSIDE. THIS SPRING ALSO HAS THE FUNCTION OF REDUCING THE LOOSENESS OF THE SCREW BY THE TENSION OF THE SPRING, SO WE DON'T THINK IT WILL LOOSEN EASILY. ALSO, THE MANUAL REQUIRES THE USE OF CAMERA COVERS WHICH REDUCES THE RISK OF FALLING. THE CAMERA COVER NOT ONLY ALLOWS THE [OPERATOR] TO ADJUST THE FOCUS, BUT ALSO PREVENTS THE CAMERA (INCLUDING SCREWS) FROM FALLING.

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT SHORTLY AFTER A CASE FINISHED ONE OF THE SCRUB TECHS NOTICED A TINY SCREW DROP INTO THE SURGICAL FIELD. ON THE FRONT OF THE CAMERA ONE OF THE FOUR PHILIPS HEAD SCREWS HAD DROPPED OUT OF THE FRONT OF THE CAMERA. NO PATIENT INVOLVEMENT, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968950 SKYTRON PRECISION HD CAMERA ONLY FOR AUT & AUA SERIES CAMERA, SURGICAL AND ACCESSORIES KQM DKK DAI-ICHI SHOMEI CO, LTD B1-715-56

    Patients

    Seq Age Sex Outcome Treatment
    1