BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    MDR report key: 3040883 · Received April 8, 2013

    Report

    Report Number
    0001811755-2013-00723
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 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

    A FOLLOW-UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION SOLDER WAS MISSING ON ONE OF THE PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE CONSOLE CAUSED TWO SUMEX DRILLS TO RUN WITHOUT USER ACTIVATION DURING A PROCEDURE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE CONSOLE CAUSED TWO SUMEX DRILLS TO RUN WITHOUT USER ACTIVATION DURING A PROCEDURE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143851 CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 CORE SUMEX DRILL5400-130-010| CORE SUMEX DRILL5400-130-010