BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15126917 · Received July 28, 2022

    Report

    Report Number
    2955842-2022-13217
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 29, 2022
    Report Date
    June 29, 2022
    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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE CONFIRMED THE REPORTED FAILURE AND REPLACED THE VIODV INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) AS A FIX. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE VIODV IESU, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: M-19 ERROR WAS FOUND POINTED TO POWER FAILURE. ADDITIONAL LOG REVIEWS CONFIRMED THAT SYSTEM SK3675 WAS USED ON (B)(6) 2022 FOR A BENIGN HYSTERECTOMY PROCEDURE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE VIODV INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A THIRD-PARTY GENERATOR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. PRODUCT EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT CONFIRMED OR REPRODUCE THE REPORTED FAILURE. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. AS A SAFETY PRECAUTION, THE UNIT WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, AN M-19 ERROR OCCURRED REPEATEDLY ON THE VIODV INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE GENERATOR WAS SHUTDOWN DUE TO THE ERROR. THE CUSTOMER POWERED THE GENERATOR BACK ON AND IT WAS SHUTDOWN AGAIN WITH THE SAME ERROR. THE SYMPTOM WOULD REPEAT AND THE GENERATOR WOULD NOT POWER ON. THE CUSTOMER DECIDED TO USE AN EXTERNAL GENERATOR TO CONTINUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS CHECKED UPON POWERING ON THE SYSTEM. THE GENERATOR INITIALLY POWERED ON WITH NO ERROR OR FAULT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE EXTERNAL GENERATOR.

    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
    2317065 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

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