BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20968915 · Received December 18, 2024

    Report

    Report Number
    2955842-2024-23393
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 25, 2024
    Report Date
    November 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO FAILED SPARK TEST WITH A VALUE OF 207. 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 IESU WAS ANALYZED, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED ON THE SYSTEM. THE IESU ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED TO THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS PROJECTING ENERGY WITHOUT THE SURGEON PRESSING THE FOOT PEDAL. THE CSR WAS NOT PRESENT WHEN THE ISSUE OCCURRED AND WAS NOT ABLE TO PROVIDE FURTHER DETAILS. THE CUSTOMER HAD THEIR FENESTRATED BIPOLAR FORCEPS INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE SYSTEM LOGS SHOWED THE 31010 ERRORS OCCURRED ON USM 1. PRIOR TO CALLING, THE CUSTOMER HAD RESEATED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ON USM 1 AS WELL AS THE ENERGY CORD, AND THE INSTRUMENT WAS FUNCTIONING NORMALLY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949375 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A

    Patients

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