BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 17015809 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14934
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    June 9, 2022
    Report Date
    June 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) FOUND THE CUT ELECTRODE WAS THERMALLY DAMAGED. MELTED CHAR MARKS WERE OBSERVED ALONG THE BLADE EDGE OF THE ELECTRODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A MESSAGE APPEARED REPEATEDLY SUGGESTING DAMAGE TO THE SYNCHROSEAL INSTRUMENT WHEN USING "SYNC" MODE. THE CUSTOMER DISCONTINUED USE OF THE INSTRUMENT AND CONTINUED THE SURGERY WITH A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE CUSTOMER INSPECTED THE INSTRUMENT AFTER THE SURGERY AND FOUND THE CUT ELECTRODE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887318 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-05 L90210919 0003 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES