BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 19159477 · Received April 22, 2024

    Report

    Report Number
    2955842-2024-13537
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 27, 2024
    Report Date
    March 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110799
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE DOUBLE CAMERA CONTROLLER (DOCO) WAS ANALYZED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE TECHNICIAN WAS UNABLE TO REPRODUCE THE FAILURE REPORT BY INSTALLING THIS DOCO INTO A TEST SYSTEM. IT STARTED UP WITH NO ERROR. RAN 50X POWER CYCLE WITH THIS BOARD, ALL PASSED. THE DOCO REMAINED IN THE TEST SYSTEM FOR DAYS, WHILE TESTING OTHER PARTS, AND IT PERFORMED WITH NO ISSUE. VIDEO TEST PASSED. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE DOUBLE CAMERA CONTROLLER (DOCO) ALONG WITH ASSY CABLE CORE TO DOCO TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE DOCO INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIOMED CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE OPERATION ROOM (OR) TEAM STATED THAT THE VISION SIDE CART (VSC) TOUCHSCREEN VISION WAS BLUR. CUSTOMER REPORTED THAT WHITE COLOR FLICKERING DOTS COMING ON BOTH VSC AND SURGEON SIDE COSOLE (SSC). THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER SAID THAT THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. IT IS UNKNOWN IF THE CONVERSION TO LAPAROSCOPIC SURGERY RESULTED IN INCREASING PORT SIZE INCISION OR ADDITION OF ADDITIONAL PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823444 DAVINCI SI VISION SIDE SYSTEM, RECERTIFIED NAY INTUITIVE SURGICAL, INC 380690-02 N/A 00886874110799

    Patients

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