BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 4213246 · Received October 30, 2014

    Report

    Report Number
    0001811755-2014-03838
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF BIAS CURRENT MESSAGE WAS DUPLICATED AND CONFIRMED DURING SERVICE EVALUATION. THE PROBABLE CAUSE OF THE ISSUE WAS DETERMINED TO BE A DAMAGE OF THE CABLE ASSEMBLY.

    Description of Event or Problem · 1

    DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY, IT WAS REPORTED THAT THE CORE SUMEX DRILL DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696643 CORE SUMEX DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1