BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSX HANDPIECE

    MDR report key: 3070994 · Received April 22, 2013

    Report

    Report Number
    0001811755-2013-00852
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION, THE VALVE GUIDE, BACKCAP ASSEMBLY, AND VALVE ACTUATION BUTTON AND ROD WERE FOUND TO BE BROKEN/WORN. PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE DEVICE AND IT WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE ESSX HANDPIECE WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, EXPOSED WIRE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172927 ESSX HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1