BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTONBLADE

    MDR report key: 6679528 · Received June 29, 2017

    Report

    Report Number
    3011394215-2017-00007
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 9, 2017
    Report Date
    June 9, 2017
    Manufacturer
    INVUITY, INC
    Product Code
    GEI
    UDI-DI
    00816728020158
    PMA / PMN Number
    K162053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A BREAST BIOPSY PROCEDURE, THE PHYSICIAN NOTED A SMALL AMOUNT OF ENERGY DISCHARGE COMING FROM THE SHAFT OF THE DEVICE. THIS RESULTED IN A SMALL BURN (<1 MM) AT THE OPENING OF THE INCISION. THE DOCTOR REMOVED THE AFFECTED TISSUE AND CLOSED THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457742 PHOTONBLADE PHOTONBLADE GEI INVUITY, INC PB1 UNKNOWN 00816728020158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention