BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14599019 · Received June 3, 2022

    Report

    Report Number
    2955842-2022-12036
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 5, 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
    WA, US
    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 COMPLAINT. DURING FIELD EVALUATION, FSE WAS UNABLE TO REPRODUCE THE REPORTED COMPLAINT DURING TESTING. THE SYSTEM BOOTED WITH NO ERROR. THE LOGS SHOWED NO MALFUNCTION OF THE IESU OR E-100 GENERATOR. AS PART OF SERVICE, FSE REARRANGED THE PEDALS AND CABLES PROPERLY AND PERFORMED ANOTHER SYSTEM TEST DRIVE USING THE E-100 AND IESU GENERATORS AND NO TROUBLE WAS FOUND. SYSTEM WAS CONFIRMED TO BE WITHIN SPECIFICATION AND VERIFIED AS READY FOR USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A MYOMECTOMY PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM SK3898 MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE AND ISI FSE'S INVESTIGATION THIS COMPLAINT IS CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT AN INTUITIVE SURGICAL, INC. (ISI) INSTRUMENT AUTO FIRED. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT WHEN THE SURGEONS SAT AT THE SURGEON SIDE CONSOLES (SSC1 AND SSC2) ONE OF THE ENERGY INSTRUMENTS AUTO FIRED. THE CUSTOMER EXPLAINED NEITHER OF THE SURGEONS AT THE SSCS WERE APPLYING A FOOT PEDAL WHEN THE ENERGY ACTIVATED OR AUTO FIRED. THE CUSTOMER WAS UNCERTAIN IF THE BIPOLAR OR MONOPOLAR INSTRUMENT WAS FIRED. CUSTOMER EXPLAINED THAT THE ENERGY AUTO FIRED UNTIL THEY REMOVED THE BIPOLAR AND MONOPOLAR ENERGY CABLES FROM THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE GENERATOR. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER EXPLAINED THEY HAD THE BIPOLAR AND MONOPOLAR CABLES CONNECTED TO THE PROPER ENERGY PORTS ON THE ERBE AND BOTH CABLES WERE ALIGNED PROPERLY. THE REPORTER STATED THAT VISION SIDE CART (VSC) FOOT PEDAL DRAWER WAS CLOSED. THE CUSTOMER RESEATED THE ENERGY CABLES AND PROCEEDED WITH THE PROCEDURE AT THE TIME OF THE CALL. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306552 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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