BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15635716 · Received October 19, 2022

    Report

    Report Number
    2955842-2022-14695
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 19, 2022
    Report Date
    September 19, 2022
    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
    IL, 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 COMPLAINT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE USM WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE OF DIFFICULTIES REMOVING INSTRUMENTS COULD NOT BE CONFIRMED OR REPRODUCED. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE. THE USM WAS ALSO TESTED ON A PFTP AND PASSED THE LISSAJOUS, SENSORS CHECK, BRAKE TEST, AND FIBER TESTS, SEVERAL INSTRUMENTS WERE INSTALLED (LARGE NEEDLE DRIVER, FENESTRATE BIPOLAR FORCEPS, 0-DEGREE CAMERA, STAPLER 45, AND VESSEL SEALER) AND ALL WERE REMOVED WITH NO PROBLEMS. THE CARRIAGE TOP PLATE WILL BE REPLACED AS A PRECAUTION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. A REVIEW OF THE PROCEDURE LOG SHOWED A PROCEDURE WAS PERFORMED ON (B)(6) 2022 ON SYSTEM SK2873. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A USM WAS IN AN UNACCEPTABLE STATE AFTER THE START OF THE PROCEDURE AND REQUIRED REPLACEMENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE FIELD SERVICE ENGINEER (FSE) THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WAS DIFFICULT TO REMOVE INSTRUMENTS ON MULTIPLE OCCASIONS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION VIA FOLLOW-UP. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028330 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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