BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 8992471 · Received September 11, 2019

    Report

    Report Number
    2955842-2019-10699
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED A PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPRODUCED THE REPORTED FAILURE ERROR 25520 ON THE MASTER TOOL MANIPULATOR (MTM) DURING CALIBRATION VIA MATLAB. THE MASTER JUNCTION BOARD (MJB) PRINTED CIRCUIT ASSEMBLY (PCA) WILL BE REPLACED. IN ADDITION, THE EMBEDDED SERIALIZER IN MASTER BASE (ESMB) BOARD AND THE MAIN WIRE HARNESS WILL BE REPLACED DUE TO ERROR 1. THE OPTO BUTTON PADS AND THE GIMBAL GRIP PADS WERE NOTED TO BE WORN OUT AND WILL BE REPLACED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN D10, G3, G4, G7, H2, H3, H6, H10 AND H11. 67 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REMOTE ARM CONTROLLER (RAC) UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPRODUCE THE REPORTED COMPLAINT ON THE RAC. THE UNIT WAS TESTED WITH THE TEST SYSTEM AND NO ERRORS/ISSUES WERE NOTED.

    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.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PARTS (MASTER TOOL MANIPULATOR AND REMOTE ARM CONTROLLER) HAVE NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED REPEATED NON-RECOVERABLE ERROR 25520. THE CUSTOMER TRIED TO RESTART THE SYSTEM SEVERAL TIMES WITH NO SUCCESS. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND NOTED ERROR 25520 POINTING TO REMOTE ARM CONTROLLER 1 (RAC1) AND ERROR 1 POINTING TO MASTER TOOL MANIPULATOR LEFT (MTML). THE TSE GUIDED THE CUSTOMER TO SWITCH OFF THE SYSTEM AND POWER CYCLE THE CIRCUIT BREAKER; HOWEVER, THE REPORTED ISSUE REMAINED. THE SURGEON DECIDED TO CONVERT TO A LAPAROSCOPIC SURGERY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE IDENTIFIED AND REPLACED MTM AND RAC DUE TO REPEATED NON-RECOVERABLE ERRORS 25520. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792654 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-15

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES