BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16057837 · Received December 27, 2022

    Report

    Report Number
    2955842-2022-16148
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    November 29, 2022
    Report Date
    November 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A VIDEO PROCESSOR (VP) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE VP WAS ANALYZED AND FOUND TO HAVE NO ISSUE. FAILURE ANALYSIS WAS NOT ABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT DURING IN-HOUSE TESTING. THE VP WAS INSERTED INTO THE TEST EQUIPMENT TO RUN FUNCTIONAL TEST. THEN FAILURE ANALYSIS CHECKED FOR FAILURES AND RAN POWER CYCLE 10 TIMES. THE TOTAL TEST TOOK 6.5 HOURS. THE RESULT WAS NO FAILURE FOUND. DURING THE TEST, TECHNICIAN NOTICED ERRORS 48259 AND 1155 OCCURRED IN THE ERROR LOG NUMEROUS TIMES. THESE ERRORS PRETEND TO THE VIDEO CAMERA ALGORITHM (VCA) 1 CHIP WHICH LOCATED ON THE DUAL WINDOW APPLIANCE (DWA) BOARD. AS A PRECAUTIONARY MEASURE, THE DWA BOARD WILL BE REPLACED. THE SYSTEM RETURNED WITH DIRTY FILTER, OTHERWISE IT IS IN A GOOD CONDITION.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SSC LOST VISION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE VIDEO PROCESSOR (VP). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A LOG REVIEW CONFIRMED THE RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE ON (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE FSE REPLACED THE VIDEO PROCESSOR DUE TO SSC VIDEO LOSS DURING THE PROCEDURE. 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. ADDITIONALLY, THE PROCEDURE WAS DELAYED BY GREATER THAN 30 MINUTES AND THE TOTAL OPERATIVE TIME IN UNKNOWN.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) LOST VISION. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE ERROR LOGS AND IDENTIFIED COMMUNICATION ISSUES WITH THE VIDEO PROCESSOR (VP). THE TSE GUIDED THE CALLER THROUGH A HARD POWER CYCLE WHICH DID NOT RESOLVE THE ISSUE. THE TSE GUIDED THE CALLER TO SHUT DOWN THE SYSTEM AND DISCONNECT AND RESEAT ALL BLUE FIBER CABLES. AFTER RESTART, ALL UNIVERSAL SURGICAL MANIPULATOR (USM) LEDS WERE YELLOW. THE TSE GUIDED THE CALLER TO REMOVE THE INSTRUMENTS, INCLUDING PRESSING THE E-STOP TO REMOVE THE PROGRASP FORCEPS WITH THE INSTRUMENT RELEASE KIT (IRK). AFTER ALL INSTRUMENTS WERE REMOVED, THE TSE GUIDED THE CALLER TO RECOVER FROM THE E-STOP, REINSTALL INSTRUMENTS, AND ALL WORKED NORMALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE ON 7-DEC-2022 AND 8-DEC-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS DELAYED BY 60 TO 70 MINUTES. PROCEDURE RADICAL PROSTATECTOMY WITH PELVIC LYMPH NODE DISSECTION - TOTAL OPERATIVE TIME 11:15 TO 16:30 (5 HR 15 MIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139712 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A

    Patients

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