BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    MDR report key: 3051407 · Received April 10, 2013

    Report

    Report Number
    0001811755-2013-00742
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE PASSED ALL ELECTRICAL SAFETY TESTING AS WELL AS A FUNCTION INSPECTION. THE ONLY FAILURE FOUND WITH THE CONSOLE WAS THE PLASTIC HOUSING OF THE POWER ENTRY ASSEMBLY WAS CRACKED. THIS WOULD NOT CAUSE A HANDPIECE TO RUN WITHOUT ACTIVATION. A FOOTSWITCH WAS ALSO REPORTED AND EVALUATED FOR THIS COMPLAINT. THE FOOTSWITCH WAS FOUND TO HAVE A WEAK CONNECTION BETWEEN THE CABLE AND CONNECTOR; THIS FAILURE CAN CAUSE A HANDSWITCH TO RUN WITHOUT ACTIVATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP WAS BEING USED WITH A TPS BI-DIRECTIONAL FOOTSWITCH WHEN IT CAUSED UNREPORTED AMOUNT OF CORE MICRO DRILLS TO RUN WITHOUT USER ACTIVATION DURING CASES. IN ONE SPECIFIC EVENT, IT CAUSED A BILATERAL ANKLE REPLACEMENT PROCEDURE TO BE CANCELLED HALFWAY THROUGH. ATTEMPTS TO OBTAIN FURTHER DETAIL REGARDING THESE EVENTS WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP WAS CAUSING AN UNREPORTED AMOUNT OF HANDPIECES TO RUN WITHOUT USER ACTIVATION DURING CASES. IN ONE SPECIFIC EVENT, IT CAUSED A BILATERAL ANKLE REPLACEMENT PROCEDURE TO BE CANCELED HALFWAY THROUGH. ATTEMPTS TO OBTAIN FURTHER DETAIL REGARDING THESE EVENTS WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149831 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 TPS BI-DIRECTIONAL FOOTSWITCH (B)(4)| CORE MICRO DRILL (B)(4)