BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSA EXCEL CONSOLE

    MDR report key: 502302 · Received December 19, 2003

    Report

    Report Number
    1222895-2003-00010
    Event Type
    Injury
    Date Received
    December 19, 2003
    Report Date
    December 1, 2003
    Manufacturer
    RADIONICS
    Product Code
    LBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL WAS PERFORMING A PROCEDURE USING THE CUSA EXCEL WITH A 36KHZ HANDPIECE WITHOUT USING A NOSECONE. THE DOCTOR WENT TO HAND OFF THE RECENTLY USED AND HOT HANDPIECE TO HOSPITAL EMPLOYEE AND THE DOCTOR ACCIDENTLY STEPPED ON THE FOOTPEDAL CAUSING A BURN TO THE EMPLOYEE. THE HOSPITAL BELIEVES THAT IT WAS CAUSED BY USER ERROR BUT ARE DOING A THOROUGH INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA EXCEL CONSOLE ULTRASONIC ASPIRATOR LBK RADIONICS CUSAEXCEL U9L406S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other