BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16488530 · Received March 6, 2023

    Report

    Report Number
    2955842-2023-11091
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 6, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM 1 HAD TREMORS/NONINTUITIVE MOTION, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE PERFORMED A TEST DRIVE ON THE SYSTEM. INITIALLY THEY HAD THE BOOM AND OUTER PITCH (OP) FULLY EXTENDED AND FULLY ROTATED, PLACING ARM 1 AS FAR AWAY FROM THE COLUMN ON THE SET UP JOINT AS POSSIBLE. WHILE WORKING/MANIPULATING INSTRUMENTS IN A SHALLOW SETUP (AS THE CUSTOMER IS A CHILDREN¿S HOSPITAL AND SURGICAL SITE IS A VASTLY SMALLER FIELD TO WORK IN), THE FSE WAS ABLE TO REPRODUCE TREMORING WHILE THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS COMPLETELY COLLAPSED. THE INSTRUMENT TIP SHOWED SHAKING WHEN PUSHING INTO THE PHYSICAL LIMIT OF THE CARRIAGE OR USM. THE FSE WORKED WITH THE ROBOTIC COORDINATOR TO ADVISE STAFF ON PLACING TROCARS IN A POSITION THAT ALLOWS THE USMS TO BE EXTENDED AND AVOID RUNNING INTO THE PHYSICAL LIMIT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING ARM 1 HAD TREMORS/NONINTUITIVE MOTION WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE DA VINCI ARM MOVED WITH UNINTUITIVE MOTION. UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PEDIATRIC UROLOGY SURGICAL PROCEDURE, ARM 1 HAD TREMORS/NONINTUITIVE MOTION. THE CUSTOMER FOLLOWED UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR) ASKING ABOUT THE CASE FROM THAT DAY DURING WHICH ARM 1 HAD SOME NONINTUITIVE MOTION. THE CUSTOMER HAD COMPLETED CASES AFTER WITH NO ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550405 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