BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL TRIGGER ROTARY

    MDR report key: 2130409 · Received May 9, 2011

    Report

    Report Number
    1811755-2011-01655
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 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 SENT FROM AN INTERNATIONAL DISTRIBUTION CENTER TO THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE LEAKING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, SERVICE WAS PERFORMED ON THE DEVICE, AND IT RECEIVED A CLEAN, LUBE, AND ADJUST. THE HANDPIECE WAS REPAIRED AND RETURNED TO THE CUSTOMER. A SAMPLE WAS TAKEN FOR TESTING, AND A F/U REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE LEAKED A BROWN SUBSTANCE. 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 DUAL TRIGGER ROTARY KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK