BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR SEALER AQM SBS 5.0

    MDR report key: 6213535 · Received December 29, 2016

    Report

    Report Number
    1226420-2016-00199
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K111732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. 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

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

    Description of Event or Problem · 1

    DURING A TRANSSPHENOIDAL CASE, THE SURGEON REPORTED SALINE RUN OFF DOWN THE PATIENT¿S LEFT NOSTRIL CAUSING A ½ X 1 INCH BURN. THE DEGREE OF THE BURN IS UNKNOWN. THERE WERE NO INTERVENTIONS REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863624 BIPOLAR SEALER AQM SBS 5.0 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 23-312-1 PHF236K5

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR