BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17015619 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14748
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    July 1, 2020
    Report Date
    July 1, 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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE CONFIRMED THE UNIVERSAL SURGICAL MANIPULATOR #4 WAS UNRESPONSIVE. FSE REPLACED THE USM #4. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED/REPLICATED THE REPORTED COMPLAINT. THE UNIT WAS TESTED ON THE IN-HOUSE SYSTEM AND IT TRIGGERED ERROR 32098 UPON THE SYSTEM STARTUP. ERRORS 23138 AND 32098 WERE CONFIRMED VIA ERROR LOGS. VISUAL INSPECTION WAS PERFORMED AND FOUND FLUID INTRUSION ON THE CIRCUIT BOARD AND CABLE CONNECTORS INSIDE THE USM. ALL AFFECTED ELECTRONIC COMPONENTS WERE REPLACED TO RESOLVE ERROR 32098. THE UNIT PASSED DIRECTION TEST, FIBER TEST, FAN TESTS, BRAKE TESTS, FRICTION TESTS, SENSOR CHECK TEST, CARRIAGE STRENGTH TESTS AND CARRIAGE SWITCH TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED REPEATED RECOVERABLE ERROR CODE 23138 WHILE ATTEMPTING TO DOCK THE PATIENT SIDE CART (PSC). THE CUSTOMER POWER CYCLED THE SYSTEM AND RE-DRAPED THE UNIVERSAL SURGICAL MANIPULATOR #4 (USM) WITH NO SUCCESS. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HELPED THE CUSTOMER PERFORM A HARD POWER CYCLE ON THE SYSTEM; HOWEVER, THE ERRORS PERSISTED. THE SURGEON NEEDED TO USE ALL USMS FOR THE PROCEDURE AND REQUESTED FOR THE ISI FIELD SERVICE ENGINEER'S SERVICE. THERE WAS NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. NO PATIENT RELATED INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916404 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES