BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15263463 · Received August 20, 2022

    Report

    Report Number
    2955842-2022-13569
    Event Type
    Malfunction
    Date Received
    August 20, 2022
    Date of Event
    July 21, 2022
    Report Date
    July 21, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    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. THE FSE REPLACED THE SET UP JOINT (SUJ) TO REPAIR COMMUNICATION ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE SUJ INVOLVED WITH THIS COMPLAINT, BUT THE DEVICE EVALUATION IS PENDING COMPLETION. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 26002: THE MIDDLEMAN ON THE PCTP IN THE PSC HAD A FAILURE IN BP EXECUTION FOR USM3, BPCODE: BP_AMP_SWITCH_MANIP (THIS CAN BE CAUSED BY ARM CHAIN COMM FAILURE). THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: THE CUSTOMER ABORTED AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERRORS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT 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 SETUP JOINT (SUJ) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPRODUCE THE REPORTED FAILURE OF ERRORS. THE UNIT WAS TESTED ON THE PFTP MACHINE AND FAILED FOR THE NODE CHECK. UPON INSPECTING FIBER OPTIC CONNECTION TO AXES CONTROLLER SETUP (ACU), IT WAS FOUND THAT THE CONNECTOR WAS NOT SEATED PROPERLY. AFTER SEATING THE CONNECTOR PROPERLY, THE TEST WAS RETRIED, AND THE UNIT PASSED ALL TEST. AS A PRECAUTION, THE FIBER OPTIC WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, NON RECOVERABLE FAULTS WERE OBSERVED ON THE SYSTEM. THE SITE PERFORMED THREE POWER CYCLES PRIOR TO CALLING TECHNICAL SUPPORT. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND FAULTS ON ARM NET 3. THE TSE PROVIDED THE OPTION OF DISABLING ARM NET 3, BUT SURGEON STATED ALL 4 ARMS WERE REQUIRED TO COMPLETE THE CASE. THE SITE CHOOSE NOT TO CONTINUE THE CASE WITH THE SYSTEM. A FOLLOW-UP WITH A FIELD SERVICE ENGINEER (FSE) WAS REQUESTED. THE PROCEDURE WAS ABORTED PRIOR TO STARTING WITH NO REPORTED INJURY. ISI HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    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
    301863 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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