BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20783336 · Received November 26, 2024

    Report

    Report Number
    2955842-2024-22433
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 31, 2024
    Report Date
    October 31, 2024
    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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE FSE FOUND THAT THE UNIT HAD EXCESSIVE NOISE AND FRICTION WHEN MOVING AROUND THE YAW AND PITCH AXES. UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED NO ERRORS BUT WAS FOUND TO BE NOISY AND HARD TO MOVE ON THE YAW AND PITCH AXES. UNIT WAS ALSO TESTED ON ANOTHER TEST PLATFORM WHERE IT PASSED ALL TESTS THAT WERE RELATED TO THE REPORTED PROBLEM. DURING INVESTIGATION, THE YAW AND PITCH AXES WERE BOTH NOISY AND STIFF.

    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 FOUND THAT THE UNIT HAD EXCESSIVE NOISE AND FRICTION WHEN MOVING AROUND THE YAW AND PITCH AXES. THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED NO ERRORS BUT WAS FOUND TO BE NOISY AND HARD TO MOVE ON THE YAW AND PITCH AXES. UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL TESTS THAT WERE RELATED THE REPORTED PROBLEM. DURING INVESTIGATION, THE YAW AND PITCH AXES WE BOTH NOISY AND STIFF. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE SYSTEM SERIAL NUMBER ASSOCIATED WITH THIS EVENT WAS ATTEMPTED. HOWEVER, THE SEARCH DID NOT RETURN ANY RESULTS IN THE PROCEDURE HISTORY ALIGNED WITH THE CUSTOMER REPORTED EVENT. THE PROBABLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO WORN MOTOR MODULES ON THE YAW AND PITCH AXES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) 1 MOVED ON ITS OWN AND CAUSED AN ABNORMAL NOISE. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE CONFIRMED NO RELATED ERROR IN THE LOGS. BEFORE THE PHONE CALL, THE CUSTOMER HAD POWER CYCLED THE SYSTEM TO RESOLVE THE NOISE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410885 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A 00886874110720

    Patients

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