BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 20754127 · Received November 21, 2024

    Report

    Report Number
    2955842-2024-22245
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 6, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE AS THERE WERE NO TANKS OR GAS CONNECTED TO THE INSUFFLATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) CALLED IN TO REPORT THAT THE INSUFFLATOR KICKED THEM OUT OF STANDARD MODE. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO RELATED ERRORS IN THE LOG. THE TSE SHARED SEVERAL POSSIBILITIES FOR CANCELING STANDARD MODE (WAITING 10 MINUTES, CHANGING THE FLOW RATE, OR TURNING ON THE SMOKE EVACUATION). THE SITE SELECTED STANDARD MODE AGAIN, BUT THE ISSUE PERSISTED. THE SITE ELECTED TO MOVE ON WITH A THIRD-PARTY INSUFFLATOR. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A CONVERSION GASTRIC SLEEVE TO ROUX-EN-Y GASTRIC BYPASS. THE PROCEDURE WAS ABLE TO BE COMPLETED ROBOTICALLY ONCE SWITCHED OVER TO THE THIRD-PARTY INSUFFLATOR. THE PROCEDURE WAS DELAYED BY 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798579 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES