BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22364761 · Received June 30, 2025

    Report

    Report Number
    2955842-2025-26441
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 6, 2025
    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
    ID, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. WHILE THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS GATHERING ADDITIONAL INFORMATION REGARDING THE TROUBLESHOOTING STEPS TAKEN, THE CHARGE NURSE INTERVENED AND ADJUSTED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2, AFTER WHICH THE BOUNCING CEASED. THE ISI FIELD SERVICE ENGINEER (FSE) LATER FOLLOWED UP WITH AN ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO CONFIRMED THAT THE SAME SURGEON WHO INITIALLY REPORTED THE ISSUE PERFORMED SUBSEQUENT PROCEDURES USING THE SYSTEM WITHOUT RECURRENCE OF THE ISSUE OR ADDITIONAL COMPLAINTS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND PHONE SUPPORT DETAILS. THE STAFF CONFIRMED NO MORE ISSUES DETECTED AFTER THEY READJUSTED THE USM IN ORDER TO RESOLVE THE PROBLEM AND THE SYSTEM LOGS DID NOT SHOW ANY RELATED ERROR, THEREFORE IT WAS UNABLE TO CONFIRM THE REPORTED FAILURE. MOST COMMON CAUSES OF THIS ISSUE IS USM MAY HAVE EXPERIENCED A TEMPORARY LOSS OF STABILITY DUE TO INCOMPLETE OR IMPRECISE ENGAGEMENT WITH THE CANNULA, LEADING TO BRIEF DRIFT BEHAVIOR, EXTERNAL FORCES (E.G., INADVERTENT BUMPING OF THE ARM OR MOVEMENT OF THE CANNULA DURING SETUP) MAY HAVE INTRODUCED UNINTENDED MOTION OR SURGICAL DRAPES WERE NOT APPLIED TOO TIGHTLY AROUND THE AFFECTED ARMS, AS THIS CAN IMPEDE PROPER MOVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THAT A CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) MID-SURGICAL PROCEDURE TO REPORT THAT UNIVERSAL SURGICAL MANIPULATOR 2 (USM2) WAS WIGGLY. THE SURGEON NOTED THAT THE USM2 WAS BOUNCING, AND THE CUSTOMER ADJUSTED USM2, WHICH STOPPED THE BOUNCING. THE REPORTED EVENT WITH USM BOUNCING WAS LATER REPORTED AS UNRESOLVED BY THE OPERATING ROOM DIRECTOR, PROMPTING A REQUEST FOR FIELD SERVICE ENGINEER (FSE) TO CHECK THE SYSTEM. SUBSEQUENTLY, A CUSTOMER WAS CONTACTED TO PROVIDE SOME PICTURES OR VIDEO TO HELP NARROW DOWN THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399044 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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