BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTONGUIDE

    MDR report key: 12280154 · Received August 5, 2021

    Report

    Report Number
    12280154
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    May 13, 2021
    Report Date
    August 2, 2021
    Manufacturer
    INVUITY, INC.
    Product Code
    FSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LUMPECTOMY PROCEDURE, IT WAS NOTED THAT THE PLASTIC DISPOSABLE END PIECE OF THE PHOTONGUIDE HAD BROKEN OFF AND THE LIGHT, FROM THE BREAST RETRACTOR, BURNED THE SKIN OF THE PATIENT. THE BROKEN PIECE WAS FOUND ON THE SURGICAL DRAPE AND PASSED OFF THE FIELD. THE LIGHT RETRACTOR WAS IMMEDIATELY TURNED OFF. THE SURGEON ASSESSED THE BURN, AND APPLIED BACITRACIN OINTMENT AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180322 PHOTONGUIDE LIGHT, SURGICAL, CARRIER FSZ INVUITY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA Other