BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17229823 · Received June 29, 2023

    Report

    Report Number
    2955842-2023-16696
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 7, 2023
    Report Date
    June 7, 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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RECOVERABLE ERRORS 32100, 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 32100 ERRORS POINTING TO DISTAL SUJ1. THE FSE SWAPPED DISTAL SET UP JOINT (SUJ) 4 TO SUJ 1 AND INSTALLED A NEW SUJ ON ARM NET 4. 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 SUJ WAS TESTED ON THE PSC FIXTURE TEST PLATFORM (PFTP) MACHINE AND PASSED ALL TESTS. THIS TYPE OF ERROR SHOWED UP ON ERROR LOG HISTORY POINTING TO AXES CONTROLLER TORNADO (ACT). AS A FIX, THE ACT PCA, LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS) HARNESS, AND THE SETUP FRU LOWER (SFL) WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED MULTIPLE RECOVERABLE ERRORS 32100 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AS THE PROCEDURE WAS FINISHING UP. THE CUSTOMER WOULD RECOVER THE FAULT, HOWEVER IT WOULD WORK FOR A SHORT WHILE THEN ERROR OUT AGAIN. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND IDENTIFIED ERROR 32100 WAS POINTING TO AC_1B IN THE DISTAL SETUP JOINT. THE CUSTOMER WAS CONTINUED WITH FINISHING UP THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY AFTER DISABLING THE USM TOWARDS THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308991 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

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