BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTS_PRODUCT

    MDR report key: 3191311 · Received June 26, 2013

    Report

    Report Number
    0001811755-2013-01466
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, BIAS CURRENT WARNING, WAS NOT DUPLICATED. DURING FUNCTIONAL INSPECTION, THE SERVICE TECHNICIAN NOTED NO FAILURES OR MALFUNCTIONS WERE OBSERVED. AFTER THE FUNCTIONAL INSPECTION THE HANDPIECE WAS DISASSEMBLED AND VISUALLY INSPECTED. DURING THIS VISUAL INSPECTION THE SERVICE TECHNICIAN OBSERVED NO COMPONENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE DEVICE WAS SERVICED FOR PREVENTATIVE MAINTENANCE AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN HANDPIECE WAS BEING USED WITH A 64:1 REDUCER AND A 1:1 HEAD WITH EXTERNAL IRRIGATION DURING A PROCEDURE WHEN A BIAS CURRENT MESSAGE WAS DISPLAYED ON THE CONSOLE. THE BIAS CURRENT MESSAGE SIGNALS A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WIT NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN HANDPIECE WAS BEING USED WITH A 64:1 REDUCER AND A 1:1 HEAD WITH EXTERNAL IRRIGATION DURING A PROCEDURE WHEN A BIAS CURRENT MESSAGE WAS DISPLAYED ON THE CONSOLE. THE BIAS CURRENT MESSAGE SIGNALS A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WIT NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290846 UNKNOWN_INSTRUMENTS_PRODUCT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 64:1 REDUCER (B)(4)| 1:1 HEAD WITH EXTERNAL IRRIGATION (B)(4)