BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19008932 · Received March 29, 2024

    Report

    Report Number
    2955842-2024-12870
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 29, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE REPLACED THE MASTER TOOL MANIPULATORS (MTM). 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. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MTM WAS ANALYZED AND FOUND TO HAVE GRAVITY COMP FAILURE ALONG AXIS 4 VIA MATLAB TESTING. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE UNIVERSAL SURGICAL MANIPULATOR -2 (USM 2) MOVED WHILE THE SURGEON WAS IN CONTROL OF THE MASTER TOOL MANIPULATOR (MTM) AND HEAD WAS IN THE VIEWER. THE INSTRUMENT MOVED ON ITS OWN WHILE THE SURGEON'S HAND WAS NOT HOLDING THE MTM UPON RELEASE. IT KEPT WANTING TO POINT THE INSTRUMENT UP, AND THE SURGEON HAD TO ACTIVELY HOLD IT DOWN (FROM POINTING UP). THE REPORTED ISSUE WAS PERSISTENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT UNIVERSAL SURGICAL MANIPULATOR 2 (USM) WAS DOING "ITS OWN THING." THE CUSTOMER ELABORATED THAT THE ISSUE HAS BEEN ONGOING, AND THE INSTRUMENT WOULD ARTICULATE ON ITS OWN. THE ERROR 23075 WAS OBSERVED ON MASTER TOOL MANIPULATOR LEFT (MTML). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ASKED IF THE ISSUE WAS ISOLATED TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 OR OCCURRING ON USM 1 AS WELL; THE CUSTOMER ORIGINALLY REPORTED THE ISSUE ON THE USM 2 BUT THE SURGEON SAID THE ISSUE WAS ONLY WITH MTML. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE ISI TSE WAS NOTIFIED. THE MTM AND USM WERE NOT DISABLED/DISCONTINUED. THE CUSTOMER STATED THAT ARM 2 MOVED WHILE THE SURGEON WAS IN CONTROL OF THE MTM, AND HEAD WAS IN THE VIEWER AND THAT THE INSTRUMENT MOVED PERSISTENTLY UNLESS THE SURGEON HELD THE MTM. IT KEPT WANTING TO POINT THE INSTRUMENT UP, AND THE SURGEON HAD TO ACTIVELY HOLD IT DOWN TO KEEP IT FROM POINTING UP. THE SURGEON CONTINUED THE PROCEDURE AND WAS ABLE TO CONTROL THE USM OR PUT IT SOMEWHERE SAFELY, SO IT HAD ROOM TO MOVE AROUND WITHOUT INJURING ANY ANATOMICAL STRUCTURES. THE PROCEDURE WAS ROBOTICALLY COMPLETED WITH ALL 4 ARMS. THE ISSUE DID OCCUR WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER, WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON SIDE CONSOLE (SSC). THE ISSUE HAD BEEN HAPPENING ON AND OFF FOR SOME TIME. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241341 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-21 N/A 00886874110744

    Patients

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