BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 19139948 · Received April 18, 2024

    Report

    Report Number
    2955842-2024-13418
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECTION AND FOUND ERROR M-02 ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE FSE REPLACED THE IESU TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU ¿VIO DV GENERATOR INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERROR M-02-7 ON NEUTRAL PAD ON START WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. M-02//M-31/M-37 ERRORS APPEARED IN THE ERROR LOG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DISPLAYED REPEATED ERROR M-02. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER REBOOT THE IESU, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND THERE WERE NO ISSUES NOTED DURING SET UP OF THE SYSTEM. THE ISSUE OCCURRED BEFORE STARTING THE SURGICAL PROCEDURE. NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE IDENTIFIED. IT WAS UNKNOWN IF THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS PLACED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241535 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-45 N/A 00886874114742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES.