BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENSEAL TRIO

    MDR report key: 911537 · Received September 11, 2007

    Report

    Report Number
    3004158985-2007-00001
    Event Type
    Other
    Date Received
    September 11, 2007
    Date of Event
    August 13, 2007
    Report Date
    August 13, 2007
    Manufacturer
    SURGRX, INC.
    Product Code
    GEI
    PMA / PMN Number
    K070165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE DEVICE DID NOT SHOW ANY SIGNIFICANT DAMAGE. THE DEVICE WAS TESTED FOR PERFORMANCE AND PASSED SPECIFICATION REQUIREMENTS. CONCLUSION: NO PROBLEM FOUND - THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    A TOTAL LAPAROSCOPIC HYSTERECTOMY/TUMOR DEBULKING/BILATERAL SALPINGOOPHORECTOMY, WHICH MIGHT NORMALLY BE PERFORMED VIA LAPAROTOMY ON A PT WITH A BMI OF 59, WAS CONVERTED TO AN OPEN PROCEDURE AFTER AN ATTEMPT TO SEAL THE FIRST VESSEL WAS UNSUCCESSFUL. UNEVENTFUL RECOVERY REPORTED AT FIRST POST-OP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO ELECTROSURGICAL CUT/COAG INSTRUMENT GEI SURGRX, INC. F07G30-02

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention