BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18432845 · Received January 2, 2024

    Report

    Report Number
    2955842-2023-21665
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 12, 2023
    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
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT FURTHER. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE ISI FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE FOLLOWING CORRECTED INFORMATION: ANNEX F - HEALTH IMPACT DESC 2 CODE WAS UPDATED TO F1906.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE THE 23094 ERROR WAS TRIGGERED. THE UNIT WAS ALSO TESTED ON A TESTING PLATFORM WHERE THE CVA CHARACTERIZATION FAILED FOR THE PITCH CVA. THE UNIT ALSO FAILED SENSOR CHECKS FOR THE YAW. A GOLDEN PITCH CVA WAS INSTALLED, AND THE UNIT WAS ABLE TO PASS TESTING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE FOLLOWING CORRECTED INFORMATION: ANNEX A CODE UPDATED TO A090209.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM REFLECTED AN ERROR 23094 POINTING TO THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONVERTED TO LAPAROSCOPY WITHOUT INSERTING ADDITIONAL TROCARS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    1550329 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.