BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 5251405 · Received November 25, 2015

    Report

    Report Number
    2955842-2015-01437
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    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 · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MEDICAL GRADE POWER SUPPLY (MPGS) INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. WHEN THE PART WAS INSTALLED ON AN IN-HOUSE SYSTEM, THERE WAS NO POWER OUTPUT FROM THE POWER SUPPLY AND THE POWER SUPPLY FAN DID NOT SPIN. THE PATIENT SIDE CART (PSC) WAS RUNNING ON THE BATTERY INSTEAD OF THE POWER SUPPLY.

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) CONDUCTED ADDITIONAL INVESTIGATION OF THE SYSTEM ON SITE. THE TFS REPLACED THE MEDICAL GRADE POWER SUPPLY (MGPS) TO FIX THE POWER PROBLEM ON THE PATIENT SIDE CART (PSC). THE PART HAS NOT YET BEEN RECEIVED FOR EVALUATION BY INTERNAL FAILURE ANALYSIS. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR 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 LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE PATIENT SIDE CART (PSC) SWITCHED TO BATTERY MODE. THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT FOR ASSISTANCE. ISI TECHNICAL SUPPORT GUIDED THE CUSTOMER THROUGH REBOOTING THE SYSTEM AND CHANGING POWER OUTLETS BUT THE ISSUE PERSISTED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN SURGERY. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, ATTEMPTS WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781401 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P9B

    Patients

    Seq Age Sex Outcome Treatment
    1