BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 6133601 · Received November 29, 2016

    Report

    Report Number
    2955842-2016-00847
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISI TECHNICAL FIELD SPECIALIST (TFS) PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE MTML AND RAC. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNITS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE INVESTIGATION RESULTS ARE AS FOLLOWS: THE REPORTED FAILURE COULD NOT BE REPRODUCED; THE RAC WAS INSTALLED INTO THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM AND SINE CYCLE RAN FOR 10 MINUTES, TWO POWER CYCLES AND SAT IDLE FOR ONE HOUR, STILL NO TROUBLE WAS FOUND. THE REPORTED FAILURE WAS REPRODUCED DURING CALIBRATION OF THE MTML UNIT. VISUAL INSPECTION WAS PERFORMED AND THE OPTO BUTTON PADS AND GIMBAL GRIP PADS WERE FOUND TO BE WORN OUT. THE OPTO BUTTON PADS AND GIMBAL GRIP PADS WILL BE REPLACED. 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

    DURING A DA VINCI ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT BECAUSE THEY WERE GETTING NON RECOVERABLE SYSTEM ERROR MESSAGES. THE SITE ATTEMPTED TO HARD POWER CYCLE THE SYSTEM; HOWEVER, THE NON RECOVERABLE SYSTEM ERROR MESSAGES CONTINUED TO OCCUR. WHEN ATTEMPTING TO RESET THE BREAKER ON THE SURGEON SIDE CONSOLE (SSC), THE SITE EXPERIENCED DIFFICULTY GETTING THE SSC TO POWER BACK ON. WHEN SYSTEM POWERED ON, THE SITE EXPERIENCED NON-RECOVERABLE FAULTS POINTING TO MASTER TOOL MANIPULATOR (MTM)LEFT AND THE REMOTE ARM CONTROLLER BOARDS (RAC). AT THIS TIME, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC SURGERY. NO PATIENT HARM WAS REPORTED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783481 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1