BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17028259 · Received May 30, 2023

    Report

    Report Number
    2955842-2023-15202
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    October 20, 2021
    Report Date
    October 20, 2021
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO CONFIRM THE REPORTED PROBLEM (ERROR 32115). THE FSE REPLACED THE DISTAL SET UP JOINT (SUJ) TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DISTAL SET UP JOINT (SUJ) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT VIA THE ERROR LOGS. ACCORDING TO THE REPORT, THE UNIT HAD EXPERIENCED ERRORS 32115. THIS TYPE OF ERROR SHOWED UP ON ERROR LOG HISTORY POINTING TO THE AXES CONTROLLER TORNADO (ACT). THE UNIT WAS INSTALLED ON THE SYSTEM AND ERROR WERE TRIGGERED. THE UNIT WAS TESTED ON THE PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) MACHINE AND KEPT LOCKING UP DURING THE BRAKE TEST. AS A FIX, THE AXES CONTROLLER TORNADO (ACT) PRINTED CIRCUIT ASSEMBLY (PCA) AND THE SETUP FRU LOWER (SFL) PCA WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED AFTER THE PROCEDURE WAS CONVERTED TO REPORT THAT THEY HAD RECEIVED MULTIPLE NON-RECOVERABLE ERRORS DURING THE PROCEDURE. THE CSR ARRIVED AFTER THE CUSTOMER CONVERTED THE PROCEDURE TO LAP. THE TECHNICAL SUPPORT ENGINEER (TSE) UPLOADED ERROR LOGS AND NOTED MULTIPLE 319 ERRORS REPORTED BY ARMNET 1. ALSO NOTED ERROR 30 REPORTED BY THE ACT BOARD ON ARMNET 1. TSE ASKED IF CUSTOMER WAS WILLING TO DISABLE ARMNET 1 TO CONTINUE WITH CASE ROBOTICALLY, BUT THEY HAD MOVED BEYOND THAT POINT. NO TROUBLESHOOTING WAS ABLE TO BE PERFORMED AT TIME OF THE CALL. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE CUSTOMER CALLED IN AFTER A CASE WAS CONVERTED TO LAP BY SURGEON TO REPORT THAT THE OR TEAM HAD EXPERIENCED MULTIPLE NON-RE COVERABLE FAULTS. CALLER STATED THE SYSTEM WOULDN'T SHUT OFF DURING LAST FAULT. TSE REVIEWED LOGS AND ERROR 30 SEEM TO POINT TO THE DISTAL SET UP JOINT (SUJ) OR THE UNIVERSAL SURGICAL MANIPULATOR (USM) ON ARM1. THE CASE HAD BEEN COMPLETED LAPAROSCOPICALLY WITH NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131674 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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