BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14796044 · Received June 24, 2022

    Report

    Report Number
    2955842-2022-12349
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 24, 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
    KS
    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. THE ARMS WERE NOT RECOGNIZED BY THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR BOTH MONOPOLAR AND BIPOLAR ENERGY. ERROR 48101 WAS FOUND IN THE LOG AND POINTED TO THE VIDEO PROCESSOR (VP) AND A 'VIO-DV NOT CONNECTED' MESSAGE DISPLAYED IN THE SURGEON SIDE CONSOLE (SSC) WHEN TRYING TO FIRE ENERGY. THE FSE REPLACED THE VP AFTER THE PROCEDURE, AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PART RELATED TO THIS COMPLAINT HAS BEEN RECEIVED, BUT FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING THE COMPLETION OF PRODUCT EVALUATION AND IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. VERIFICATION VIA LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TECHNICAL SUPPORT ENGINEER (TSE) AND ISI FSE'S INVESTIGATION. THIS EVENT IS BEING REPORTED BECAUSE THE ESU WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP ESU. 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

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VIDEO PROCESSOR (VP) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED THE CUSTOMER REPORTED COMPLAINT OF ¿ARMS WAS NOT RECOGNIZED BY IESU FOR BOTH MONOPOLAR AND BIPOLAR ENERGY WITH 48101 POINTING TO VP IN LOGS AND 'VIO-DV NOT CONNECTED' MESSAGE DISPLAYED IN THE SSC WHEN TRYING TO FIRE ENERGY." THE VP WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE VP STARTED UP AND FAILED WITH ERROR 48101 AND 113. THE UNIVERSAL (UNIT) CONTROLLER CARD (UCC) 653080-07 HAD FAILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, BOTH THE MONOPOLAR AND BIPOLAR ASSIGNMENT INDICATOR ICONS IN THE INTEGRATED ELECTROSURGICAL UNIT (IESU) SHOWED AS '?' AND A 'VIO-DV NOT CONNECTED' MESSAGE DISPLAYED IN THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER PERFORMED THE FOLLOWING TROUBLESHOOTING INCLUDED RESEATED THE IESU CONTROL CABLE CONNECTION BETWEEN THE IESU AND THE VIDEO PROCESSOR (VP), CHANGED THE MONOPOLAR AND BIPOLAR ENERGY CABLES, REPLACED THE INSTRUMENT, AND PERFORMED POWER CYCLE AS WELL AS HARD POWER CYCLE OF THE SYSTEM AND THE IESU. HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER THEN USED AN EXTERNAL ESU TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: UPON POWERING ON THE SYSTEM, THE SYSTEM FUNCTIONALITY WAS CHECKED AND THERE WAS NO ERROR FOUND. THE CUSTOMER COULD NOT ACTIVATE THE MONOPOLAR AND BIPOLAR ENERGY. THE PROCEDURE WAS COMPLETED USING ANOTHER ESU. THERE WAS NO REPORT OF PATIENT INJURY. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    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
    982858 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

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