BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16797050 · Received April 24, 2023

    Report

    Report Number
    2955842-2023-12140
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    March 27, 2023
    Report Date
    March 27, 2023
    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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED AN ERROR OF 23069. THE UNIT WAS TESTED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND FAILED INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION REPLICATING THE REPORTED ISSUE. DURING TROUBLESHOOTING AND VISUAL INSPECTION, THE INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA) FLAT FLEX CABLE (FFC) WAS FOUND TO HAVE A CUT FROM TOUCHING THE CVA DISK. PERFORMED A-B-A TEST USING A GOLD INSERTION CVA FFC AND CONFIRMED THAT THE INSERTION CVA FFC WAS THE CAUSE OF FAILURE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ISSUE WITH ARM 4, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM4) TO RESOLVE THE ISSUE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI USM TO PERFORM FAILURE ANALYSIS AND THE INVESTIGATION IS IN PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: AN USM WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    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 LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED AN ISSUE WITH ARM 4. PRIOR TO CALLING IN THE ISSUE, THE CUSTOMER HAD SOFT POWER CYCLED THE SYSTEM, BUT THE ISSUE REMAINED. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND 23087 ISSUES ON ARM4 AXIS 3 RELATED TO THE ENCODER. THE TSE RECOMMENDED A HARD POWER CYCLE OF THE SYSTEM TO TRY AND RESOLVE THE ISSUE. THE CUSTOMER DECLINED AT THE TIME AND THE STAFF HAD DISABLED ARM4. THE CUSTOMER STATED THEY WOULD PERFORM THE HARD POWER CYCLE OF THE SYSTEM AT A BETTER TIME. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372200 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

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