BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3123962 · Received May 22, 2013

    Report

    Report Number
    1045834-2013-02163
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE DEVICE WAS RECEIVED FOR EVALUATION. THE CONSOLE DEVICE WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA REGARDING A CONSOLE DEVICE IN WHICH AN E6 ERROR CODE, "WHICH INDICATES THERE IS A HANDPIECE OVERHEAT WARNING," WAS DISPLAYED DURING AN EAR NOSE & THROAT PROCEDURE. THE REPORTER STATED THAT THERE WAS A ONE MINUTE DELAY IN THE SURGICAL PROCEDURE AS A RESULT. AN IDENTICAL SPARE CONSOLE DEVICE WAS AVAILABLE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226119 SYSTEM CONSOLE MOTOR, DRILL, ELECTRIC- CONSOLE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1