BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19306152 · Received May 13, 2024

    Report

    Report Number
    2955842-2024-14477
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 19, 2024
    Report Date
    April 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. FSE REPLACED ERBE TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE INTEGRATED ELECTROSURGICAL UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE (ERRORS WHEN FIRING MONOPOLAR) WAS CONFIRMED AND REPRODUCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR ON THE ERBE WAS NOT WORKING. THE CALLER STATED THAT THEY REPLACED THE CABLE AND INSTRUMENT, BUT NOTHING CHANGED. THEY DID NOT USE BIPOLAR IN THIS PROCEDURE. THEY WERE SETTING UP FORCE TRIAD, BUT SYSTEM WAS ALSO RESTRICTED DUE TO TECHNICAL ISSUES. THE SITE SWITCHED TO SYNCHROSEAL INSTRUMENT (USING E-100) INSTEAD. AN ERROR LOGS SHOWED MULTIPLE C-38, M-11, M-18 ISSUES (HF MEASUREMENT TOO LOW). THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: UPON POWERING ON THE SYSTEM, THERE WERE NO ERRORS. HOWEVER, WHEN ATTEMPTING TO USE MONOPOLAR SCISSORS WITH THE ERBE MACHINE, ERROR MESSAGES WERE DISPLAYED. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY AND PARTIALLY ROBOTICALLY. THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THE PATIENT TOLERATED THE CHANGE IN PROCEDURE. NO OBVIOUS INJURY WAS NOTICED, ALTHOUGH THE CASE TOOK LONGER TO COMPLETE INDICATED TO LESS THAN 15 MINUTES DELAY.

    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
    592485 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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