BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971341 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13989
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    June 11, 2020
    Report Date
    June 11, 2020
    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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM2) DUE TO REPEATED ERROR 23069. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPLICATED THE REPORTED FAILURE (23069 AXIS 3). WHEN THE ARM WAS TESTED ON AN IN-HOUSE SYSTEM, IT FAILED NORMAL MODE AS IT TRIGGERED 23069 DOF 4. WHEN THE UNIT WAS TESTED ON PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP), THE ARM PASSED DIRECTION TESTS, CARRIAGE SWITCHES, LISSAJOUS, CARRIAGE STRENGTH TEST, BACK DRIVE TEST, CARRIAGE SENSORS CHECK, CARRIAGE FRICTION LOW AND HIGH TEST, AND ADVANCED BRAKE TEST. DURING THE COURSE OF PFTP TESTING, THE ARM FAILED SENSOR CHECK, SINE CYCLE, INSERTION FRICTION TEST ON SPEED LOW AND SPEED HIGH. INSERTION CVA DISC, INSERTION FFC (181142) AND INSERTION CVA PCA WILL BE REPLACED AS FIX TO THE REPORTED PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, SYSTEM WAS FAULTING WITH AN ERROR ON ARM 2. LOGS SHOWED INSERTION AXIS WAS FAULTING. THEY WERE DRAPING ARM 4 AND WILL BRING THAT IN FOR THE CASE. THE SITE DISABLED ARM 2 AND THEY ARE CONTINUING WITH 3 ARMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. 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
    478316 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A

    Patients

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