BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMER IV HANDPIECE

    MDR report key: 3232155 · Received July 17, 2013

    Report

    Report Number
    0001811755-2013-01663
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 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 AT THE MANUFACTURER, DAMAGED COMPONENTS WERE FOUND INCLUDING THE BEARING, GEAR TRAIN ASSEMBLY, AND VALVE ASSEMBLY.

    Description of Event or Problem · 1

    THE HUMMER IV HANDPIECE WAS RETURNED FOR SERVICE. DURING THE SERVICE EVALUATION, THE DEVICE WAS FOUND TO OVERHEAT. 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
    332532 HUMMER IV HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1