BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTONSABER F

    MDR report key: 8201454 · Received December 27, 2018

    Report

    Report Number
    3011394215-2018-00008
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    July 11, 2018
    Report Date
    December 3, 2018
    Manufacturer
    INVUITY, INC
    Product Code
    JOL
    UDI-DI
    00816728020134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE BEING HELD BY THE (B)(6), THE LIGHTED SUCTION STARTED SMOKING AND THE PLASTIC TIP MELTED. IT WAS REMOVED FROM THE SURGICAL FIELD AND REPLACED; THERE WAS NO IMPACT TO THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE INITIAL REPORT WAS DISCOVERED VIA SEARCH OF THE MAUDE DATABASE LISTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038083 PHOTONSABER F PHOTONSABER F, 8FR STANDARD, TEARDROP JOL INVUITY, INC PSF08ST 17120802 00816728020134

    Patients

    Seq Age Sex Outcome Treatment
    1