BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18763771 · Received February 22, 2024

    Report

    Report Number
    2955842-2024-11702
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 19, 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
    TU
    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 ERROR FAULT WAS CONFIRMED THROUGH LOG REVIEW. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT PASSED. THE USM WAS TESTED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND PASSED. A DEFECTIVE PITCH MODULE WAS SUSPECTED ON THE USM ARM.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE USM INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    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 PROSTATECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED ON THE CUSTOMER'S BEHALF TO REPORT THEY WERE HAVING SOME ERRORS DURING YESTERDAY'S PROCEDURE ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE CALLER STATED THAT THE CUSTOMER WAS ABLE TO FINISH THE PROCEDURE USING 3 ARMS. TODAY, THEY PERFORMED A PROCEDURE WITH NO ISSUES, BUT THE CUSTOMER IS AFRAID OF THIS ERROR COMING BACK AND CAUSING A CONVERT/ABORT. THE TSE HAS REVIEWED ERROR LOGS AND FOUND ERRORS 23118, 23065 POINTING TO USM 1, AXIS 3. THE TSE ALSO CONFIRMED THIS ERROR OCCURRED TWICE IN THE LAST 8 DAYS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM POWERED ON WITHOUT ANY PROBLEM OR ERRORS AND ALL CHECKS HAVE BEEN DONE. THE TSE WAS CONTACTED FOR TROUBLESHOOTING DURING THE PROCEDURE AND FULL TROUBLESHOOTING WAS COMPLETED. THE SYSTEM DISPLAYED A RECOVERABLE FAULT, SO THE RECOVER FAULT BUTTON WAS PRESSED. AFTER 1 MINUTE, THE RECOVER FAULT BUTTON WAS PRESSED AGAIN, THE SYSTEM WAS UNDOCKED, AND THE ARM DRAPE CHANGED. THE SYSTEM WAS THEN RESTARTED, AND THE PROCEDURE CONTINUED UNTIL THE ERROR REOCCURRED. AT THIS POINT, THE ARM WAS DISABLED, AND THE SURGERY CONTINUED WITH ONLY 3 ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212168 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES