BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 2.3 BIPOLAR SEALER

    MDR report key: 1060617 · Received June 16, 2008

    Report

    Report Number
    1060617
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 23, 2007
    Report Date
    June 13, 2008
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC PATIENT TAKEN TO SURGERY FOR LIVER MASS. A BIPOLAR ELECTROSURGICAL DEVICE WAS USED DURING THE PROCEDURE. A GROUNDING PAD WAS PLACED ON THE LEFT SHOULDER. AFTER THE PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT SUSTAINED TWO BURNS TO THE LEFT SHOULDER AREA. THE FIRST BURN WAS A 1.5CM.X1CM FULL THICKNESS BURN AND LOCATED ON THE SUPERIOR ASPECT OF THE LEFT SHOULDER, SLIGHTLY POSTERIOR. THE SECOND BURN WAS ALSO FULL THICKNESS AND MEASURED 2CM X 3CM AND WAS LOCATED ON THE UPPER BACK JUST LATERAL AND INFERIOR TO THE SPINE OF THE SCAPULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 2.3 BIPOLAR SEALER ESU GEI SALIENT SURGICAL TECHNOLOGIES, INC. AQUAMANTYS 2.3 UNK
    2 * GROUNDING PAD ODR COVIDIEN (VALLEYLAB) E7512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| R