BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTONBLADE

    MDR report key: 10104740 · Received June 1, 2020

    Report

    Report Number
    10104740
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 21, 2020
    Manufacturer
    INVUITY, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INVUITY PHOTONBLADE CUTTING/COAGULATION ELECTROSURGICAL PENCIL WITH DYNAMIC PRECISION ILLUMINATOR WAS DEPLOYED. A BURN WAS NOTED ON THE PATIENT JUST BELOW THE SURGICAL SITE. THE PHOTONBLADE PENCIL WAS USED WITH A COVIDIEN (MONOPOLAR) ELECTROSURGICAL UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570805 PHOTONBLADE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INVUITY, INC. PB1

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Other