BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15812485 · Received November 17, 2022

    Report

    Report Number
    2955842-2022-15308
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 17, 2022
    Report Date
    October 17, 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
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED BUT DID NOT REPLICATE THE REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED NORMAL MODE. PROCEDURE LOGS SHOWED ERRORS 23118 AXIS 3. WHEN THE INSERTION AXIS WAS INSPECTED, NO DISCREPANCIES NOR PHYSICAL ISSUES WERE FOUND ON DEGREE OF FREEDOM (DOF) 4 CHIPENCODER VIRTUAL ABSOLUTE (CVA) DISK, CVA PRINTED CIRCUIT ASSEMBLY (PCA) OR FLAT FLEX CABLE (FFC). THE UNIT WAS TESTED ON PSC FIXTURE TEST PLATFORM (PFTP) AND PASSED ALL TESTS.

    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. TO CORRECT THE ISSUE, FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE REPLACED COMPONENT FOR EVALUATION, HOWEVER, AT THIS TIME, EVALUATION HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED POST-EVALUATION AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. EVENT VERIFICATION VIA LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM# (B)(4) MATCHING THE DOCUMENTED EVENT DETAILS. THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TECHNICAL SUPPORT ENGINEER (TSE) INVESTIGATION. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: FIELD SERVICE ENGINEER (FSE) INVESTIGATION CONFIRMED THE REPORTED COMPLAINT THAT OCCURRED DURING PROCEDURE, WAS NOT RESOLVED, AND REPLACED THE USM. 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.

    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 SURGICAL PROCEDURE, THE SYSTEM REPEATEDLY DISPLAYED A RECOVERABLE FAULT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. AFTER OVERRIDING THE FAULT, THE SYSTEM FUNCTIONED PROPERLY. ACCORDING TO THE ERROR LOG, AN ERROR 23118 OCCURRED REPEATEDLY ON USM1 AXIS 3. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2779367 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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