BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 3052914 · Received April 11, 2013

    Report

    Report Number
    0001811755-2013-00760
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE WAS RETURNED TO STRYKER INSTRUMENTS FOR EVALUATION DUE TO ALLEGED RUN ON DURING TESTING OR SETUP AND WOULD NOT SHUT OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156099 SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1