BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTVAC W/8 FOOT HOSE AND MOBILE STAND

    MDR report key: 2213159 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02802
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    LGH
    PMA / PMN Number
    PRE-AMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE PRODUCT SMOKING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE FILTER AND VACUUM CAUSING THE MOTOR AND PC BOARD TO FAIL. THOSE PARTS WERE EACH REPLACED ALONG WITH OTHER COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN SMOKING WHILE THE EQUIPMENT WAS BEING TESTED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTVAC W/8 FOOT HOSE AND MOBILE STAND LGH STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK