BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR

    MDR report key: 3760254 · Received April 19, 2014

    Report

    Report Number
    2520274-2014-10949
    Event Type
    Malfunction
    Date Received
    April 19, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    NI
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THAT THE REPORTED MALFUNCTION IS UNLIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. THEREFORE, THIS COMPLAINT IS NOT REPORTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO A MECHANICAL COMPONENT OR (ECU) ELECTRONIC CONTROL UNIT FAILURE DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING IN STERILE PROCESSING, IT WAS DISCOVERED THAT THE BATTERY OSCILLATOR DEVICE "RAN CONTINUOUSLY WHEN CONNECTED TO THE BATTERY". THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239128 BATTERY OSCILLATOR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY NI 3814

    Patients

    Seq Age Sex Outcome Treatment
    1