BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR AQM 115V

    MDR report key: 6131870 · Received November 29, 2016

    Report

    Report Number
    1226420-2016-00184
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 26, 2016
    Report Date
    March 31, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A SPINE CASE, UPON ACTIVATION OF THE AQUAMANTYS DEVICE, STAFF REPORTED A SPARK AND SMOKE COMING FROM THE DEVICE TIP. THE DEVICE WAS NOT NEAR THE PATIENT¿S TISSUE. THERE WAS NO HARM TO THE OR STAFF OR THE PATIENT.

    Description of Event or Problem · 1

    DURING A SPINE CASE, UPON ACTIVATION OF THE AQUAMANTYS DEVICE, STAFF REPORTED A SPARK AND SMOKE COMING FROM THE DEVICE TIP. THE DEVICE WAS NOT NEAR THE PATIENT¿S TISSUE. THERE WAS NO HARM TO THE OR STAFF OR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782979 GENERATOR AQM 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 40-402-1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR