BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S2 DRILL

    MDR report key: 3913858 · Received July 3, 2014

    Report

    Report Number
    0001811755-2014-02401
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS. A FOLLOW-UP WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF THE DEVICE RUNNING WITHOUT THE FOOTPEDAL BEING DEPRESSED WAS NOT CONFIRMED. NO UNINTENDED ACTIVATION WAS DUPLICATED DURING TESTING OF THE RETURNED HANDPIECE, AND NO FAILURE MODES THAT WOULD CAUSE OR CONTRIBUTE TO UNINTENDED ACTIVATION WERE OBSERVED IN THE DEVICE. THE DEVICE WAS SERVICED FOR PREVENTATIVE MAINTENANCE, AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE S2 DRILL WAS INTERMITTENTLY RUNNING WITHOUT USER ACTIVATION OF THE FOOT PEDAL DURING THE COURSE OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE S2 DRILL WAS INTERMITTENTLY RUNNING WITHOUT USER ACTIVATION OF THE FOOT PEDAL DURING THE COURSE OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389134 S2 DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1