BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17855245 · Received October 2, 2023

    Report

    Report Number
    2955842-2023-18907
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED 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 WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM TO PERFORM FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE USM HAS NOT BEE COMPLETED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON HAD DECIDED TO CONVERT TO OPEN NOT DUE TO FAULT ON UNIVERSAL SURGICAL MANIPULATOR (USM) #2. THE PATIENT TOLERATED THE OPEN PROCEDURE WITH NO INJURY REPORTED. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND REPORTED ERROR WAS CONFIRMED VIA REMOTE FE AND REPLICATED IN-HOUSE. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE TRIGGER 32100. THE UNIT WAS ALSO PASSED LISSAJOUS, CARRIAGE STRENGTH, AND SINE CYCLE TESTS BUT FAILED THE DIRECTION TEST. THE PARALLELOGRAM AND THE CLOCK SPRING FIBER AND FLAT FLEX CABLES (FFC'S) WERE EXAMINED, AND NO DISCREPANCY FOUND. THE AXES CONTROLLER MOTOR (ACM) WILL BE REPLACED AS A FIX THE REPORTED ISSUE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE SYSTEM HAD A RECOVERABLE FAULT. PRIOR TO CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT FOR ASSISTANCE, THE SURGEON HAD DECIDED TO CONVERT TO OPEN SURGERY. THE SYSTEM WAS GETTING AN ERROR ON THE SYSTEM POINTING TO ARM #2. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE FAULT ON ARM #2. THE TSE WALKED THE CALLER THROUGH A HARD POWER CYCLE TO TRY AND RECOVER THE SYSTEM, BUT THE ISSUE REMAINED UPON POWER UP. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL INC (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    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
    1972049 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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