BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22173499 · Received June 10, 2025

    Report

    Report Number
    2955842-2025-24406
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 15, 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
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE WAS UNABLE TO REPRODUCE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FSE'S FIELD EVALUATION. AS THE ISSUE WAS UNABLE TO BE REPRODUCED. THE FSE'S SERVICE VISIT DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT UNIVERSAL SURGICAL MANIPULATOR (USM) WAS NOT COOPERATING WELL. THE SITE COULD NOT PROVIDE FURTHER INFORMATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333402 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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