BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER

    MDR report key: 2132317 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02120
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, AN UNINTENDED ACTIVATION CONDITION WAS FOUND. BASED ON THE INVESTIGATION DETAILS, A FAULTY ROCKER SWITCH WAS SHORTING OUT DUE TO EXCESSIVE DUST IN THE END CAP OF THE DEVICE. THE SERVICE REPAIR TEAM REPLACED THE OUTPUT DRIVE ASSEMBLY AND ROCKER SWITCH IN THE DEVICE.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION, THE DEVICE HAD UNINTENDED ACTIVATION WHEN FIRST PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAST CUTTER HAB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK