BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5873 COUPLER ASSEMBLY FOR MAYFIELD HEADSET

    MDR report key: 1870330 · Received September 29, 2010

    Report

    Report Number
    2921578-2010-00012
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CURRENTLY ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE AS THE FAILED COMPONENT HAS NOT BEEN RETURNED FOR EVALUATION. A REQUEST TO THE DISTRIBUTOR IN (B)(4) FOR THE RETURN OF THE FAILED COMPONENT HAS BEEN ISSUED.

    Description of Event or Problem · 1

    DURING SURGERY, THE KNOB THAT TIGHTENS THE MAYFIELD CLAMP TO THE JACKSON TABLE ATTACHMENT BROKE AND THE PATIENT'S HEAD FELL. THE RESIDENT HELD THE HEAD IN POSITION WHILE THEY CLOSED AND THE PATIENT WAS TRANSFERRED TO A NEW BED AND A NEW ATTACHMENT WAS PLACED AND THE SURGERY WAS COMPLETED. NO INJURY OCCURRED, BUT THE SURGERY WAS PROLONGED BY 1.5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5873 COUPLER ASSEMBLY FOR MAYFIELD HEADSET OPERATING ROOM TABLE ACCESSORY JEB MIZUHO ORTHOPEDIC SYSTEMS, INC. 5873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other