BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 4120924 · Received September 26, 2014

    Report

    Report Number
    0001811755-2014-03376
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS UNABLE TO CONFIRM THE EVENT OF OVERHEATING, BUT NOTED THAT THE NOSE CONE HAD A SUBSTANCE ON IT. IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY THE NOSE CONE SUBSTANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601366 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1