BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21090669 · Received January 7, 2025

    Report

    Report Number
    2955842-2025-00079
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 10, 2024
    Report Date
    December 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) COLLABORATED WITH ROBOTICS COORDINATOR (ROCO) TO TEST THE MONOPOLAR AND BIPOLAR ENERGY CORDS PROVIDED BY THE CUSTOMER. THE FSE ALSO CONSULTED WITH THE CHAIR OF ROBOTIC MEDICINE, WHO SUGGESTED THAT THE ISSUES MIGHT HAVE BEEN DUE TO USER ERROR BUT AGREED THAT REPLACING THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WOULD HELP BOOST THE SURGEONS' CONFIDENCE IN THE SYSTEM. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED ON IESU CONNECTED TO THE SYSTEM. SYSTEM LOG REVIEW WAS PERFORMED BUT NO RELATED FAULTS WERE FOUND. VISUAL INSPECTION WAS PERFORMED AND FOUND NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL WAS IN DECENT CONDITION. THE UNIT ENERGIZED AND CAUTERIZED USING ALL PORTS AND WAS ABLE TO RECOGNIZE INSTRUMENTS ON SYSTEM. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS. DESIGN HISTORY RECORD (DHR) REVIEW FOR THE SYSTEM INVOLVED WITH THE REPORTED EVENT WAS DEEMED NOT REQUIRED BY QUALITY ENGINEER SINCE THERE IS NO INDICATION OF A MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO REPRODUCE THE ISSUE, HOWEVER, THE FSE REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) FOR CUSTOMER SATISFACTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE IESU INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. AS OF (B)(6)2024, A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED (B)(4) IS A RELATED RECORD (THE INITIAL COMPLAINT). SYSTEM LOG REVIEW SHOWS A CHOLECYSTECTOMY PROCEDURE TOOK PLACE ON (B)(6)2024 VIA SYSTEM (B)(4).

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE BIPOLAR ENERGY FAILED TO FIRE WHILE USING THE ERBE GENERATOR. THE SURGEON CONTINUED TO OPERATE WITH MONOPOLAR ENERGY ONLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PRIOR TO THE INCIDENT, SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM WAS CONFIRMED TO HAVE INITIALLY POWERED ON WITHOUT ERRORS. AS A RESULT OF THE ISSUE, THE PROCEDURE WAS COMPLETELY ROBOTICALLY WITHOUT USE OF THE ERBE GENERATOR. THE GENERATOR WAS NOT EXCHANGED OUT DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347012 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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