BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20990215 · Received December 20, 2024

    Report

    Report Number
    2955842-2024-23470
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 27, 2024
    Report Date
    November 27, 2024
    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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 RETURNED FOR NOISY INSERTION MOVEMENT. THE REPORTED PROBLEM WAS CONFIRMED AND REPLICATED. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT WAS NOTED THAT THE INSERTION MOVEMENT WAS NOISY. THE USM WAS TESTED ON A PSC FIXTURE TEST PLATFORM (PFTP) WHERE THE TECHNICIAN NOTED THAT DURING SINE CYCLE THE INSERTION WAS NOISY. THE INSERTION BRAKE WILL BE REPLACED AS THE ROOT CAUSE OF THE REPORTED PROBLEM. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN INSERTION BRAKE FRICTION PROBLEM.

    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. FSE PERFORMED TROUBLESHOOTING STEPS ON UNIVERSAL SURGICAL MANIPULATOR (USM4) MULTIPLE TIMES AND CONFIRMED ENGAGEMENT ISSUE WAS NO LONGER OCCURRING. FSE WAS UNABLE TO REPRODUCE ISSUE ON USM4. VERIFIED AND READY FOR USE. HOWEVER, WHILE ON SITE, FSE NOTICED EXCESSIVE NOISE ON USM3 INSERTION AND REPLACED USM3. THE COMPLAINT WAS NOT CONFIRMED BASED ON FIELD EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ATTEMPTED TO INSTALL A PROGRASP FORCEPS INSTRUMENT IN UNIVERSAL SURGICAL MANIPULATOR (USM4) BUT THE USM4 WOULD NOT RECOGNIZE THE INSTRUMENT. THE LOGS SHOWED ERROR 22020 SHOWING THE INSTRUMENT FAILED TO ENGAGE DUE TO FAILED WRIST PITCH AXIS. THE CUSTOMER ATTEMPTED TO RESEAT THE INSTRUMENT SEVERAL TIMES AND CHANGED IT OUT WITH A SPARE WITH NO CHANGE. THE TSE RECOMMENDED TRYING ANOTHER DRAPE ON USM4. THE CUSTOMER ELECTED TO USE THE SYSTEM AS A 3-ARM PROCEDURE USING ONLY USMS 1,2, AND 3. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE INFORMED THE CASE WAS COMPLETED WITH 3 ARMS. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049027 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES