BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971863 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14334
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    February 17, 2021
    Report Date
    February 17, 2021
    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
    CA, 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 COMPLAINT. THE FSE COULD NOT REPLICATE THE REPORTED ISSUE; HOWEVER, THE FSE REPLACED THE SYSTEM'S UNIVERSAL SURGICAL MANIPULATOR (USM) AS A PRECAUTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS ABLE TO CONFIRM AND REPLICATE THE REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND IT FAILED NORMAL MODE. DURING THE NORMAL TESTS, THE USM TRIGGERED ERRORS 23068 AND 23069, POINTING TO DEGREES OF FREEDOM (DOF) 7; WHICH IS THE SAME DOF THAT TRIGGERED ERROR 23087 IN THE LOGS. THE ERROR WAS RECOVERED AND THE NORMAL MODE TESTS WERE FINISHED. THE CARRIAGE COVER WAS REMOVED AND VISUAL INSPECTION FOUND HEAVY DEBRIS IN THE DOF 7 SENSOR AND MINOR DEBRIS IN THE DOF 5 SENSOR OF THE INSTRUMENT STERILE ADAPTER (ISA). VISUAL INSPECTION OF THE ROTORS REVEALED THAT ALL OF THE ROTOR MIRRORS WERE HEAVILY CONTAMINATED, AND THE DOF 7 ROTOR MIRROR HAD SIGNIFICANT DEBRIS. THE UNIT PASSED DIRECTION TEST, SENSOR CHECK, CARRIAGE, LISSAJOUS, SINE CYCLE, CARRIAGE FRICTION TEST, FRICTION TEST, BRAKE TEST, CARRIAGE STRENGTH TEST, CARRIAGE SWITCHES, CARRIAGE/AXES CONTROLLER, MOTOR (ACM) FAN AND FIBER TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED REPEATED RECOVERABLE ERRORS ON THE SYSTEM'S UNIVERSAL SURGICAL MANIPULATOR (USM) 4. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED ERROR 23087: HALL SENSOR/ENCODER ERROR REPORTED BY USM 4, AXIS 6. THE TSE HELPED THE CUSTOMER DISABLE THE USM 4 AND POWER-CYCLE THE SYSTEM, TO RESOLVE THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780807 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-38 N/A 00886874110720

    Patients

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