BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 PRECISION HANDPIECE

    MDR report key: 2160657 · Received June 30, 2011

    Report

    Report Number
    1811755-2011-02321
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND A SAMPLE WAS ACQUIRED FOR TESTING. BASED ON THE INITIAL INVESTIGATION DETAILS, THE LOCTITE WAS SECURE. A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING OIL DURING QC PROCESSING. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT 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 SYSTEM 6 PRECISION HANDPIECE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK