BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIP SAW

    MDR report key: 2070822 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01281
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, BUT BASED ON THE INVESTIGATION DETAILS, THE REPORTED CONDITION OF THE DEVICE LEAKING DURING USAGE COULD NOT BE DUPLICATED. THERE WAS EVIDENCE OF THIRD PARTY TAMPERING, AND SERVICE REPLACED THE MOTOR CONTROLLER AND MOTOR. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING AN OILY SUBSTANCE WHILE THE EQUIPMENT WAS BEING TESTED. THIS WAS NOT DURING A SURGICAL PROCEDURE. 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 RECIP SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK