BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14556430 · Received May 31, 2022

    Report

    Report Number
    2955842-2022-11948
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 2, 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
    OTHER HEALTH CARE PROFESSIONAL
    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. AFTER COMPLETING THE LAPAROSCOPIC PROCEDURE, THE FSE CHECKED THE ERROR LOG AND FOUND AN ERROR 48200 ON THE PMSC AND PMAV. AFTER REPLACING THE PMSC, THE IMAGE ON THE LEFT MONITOR OF THE SSC CAME BACK NORMALLY BUT ERROR 48200 STILL OCCURRED. THE FSE REPLACED THE PMAV AND THE ISSUE RESOLVED. AFTER REPLACEMENT, THE SYSTEM WAS TESTED OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PMAV INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE FAILURE ANALYSIS INVESTIGATION REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE PMAV WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. UPON POWERING, THE MODULE LOGGED AN ERROR 48200, PMAV LEAF 3 WAS NOT PRESENT ON THE GEMINI LAPTOP APPLICATION. THE VIDEO OUTPUT LEAF (VOL1) FAILED. THE PMAV WAS CONFIRMED FAULTY. ISI HAS RECEIVED THE PMSC RELATED TO THIS COMPLAINT FOR EVALUATION, BUT FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE FAILURE ANALYSIS EVALUATION AND IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS RELATED TO THIS COMPLAINT. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF THE ERROR FAULT DURING A PROCEDURE ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM SL0908 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 CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO VISION ISSUE IN THE SURGEON SIDE CONSOLE (SSC). 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.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE FAILURE ANALYSIS INVESTIGATION REPLICATED THE CUSTOMER REPORTED COMPLAINT OF ¿LEFT VISION BECAME BLACK IN SURGEON SIDE CONSOLE (SSC).¿ THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED THE VIDEO TEST. THE SSC DISPLAYED SOLID BLACK WITH NO VIDEO ON THE LEFT. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE SURGEON CONSOLE LEAF (SCL) 1 WAS THE CAUSE OF THE ISSUE. THE ROOT CAUSE WAS A COMPONENT FAILURE. ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H10. FAILURE ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE LEFT VISION OF THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. THE CUSTOMER ATTEMPTED TO REPLACE THE ENDOSCOPE WITH A SPARE ONE TO RESOLVE THE ISSUE, BUT THE ISSUE PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE SYSTEM ERROR LOGS AND FOUND ERROR 48200 ON THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) AND THE PERSONALITY MODULE AUDIO / VIDEO (PMAV). THE CUSTOMER WAS ADVISED TO REMOVE ALL DIGITAL VIDEO INTERFACE (DVI) CABLES CONNECTING TO THE PMSC AND PMAV AND REBOOT THE SYSTEM. THIS DID NOT RESOLVE THE ISSUE. FOLLOWING THIS, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE ISSUE OCCURRED AFTER 30 MINUTES INTO THE PROCEDURE. THERE WAS NO PATIENT INJURY AND NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. THE PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE.

    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
    306914 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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