BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 5615842 · Received April 28, 2016

    Report

    Report Number
    2955842-2016-00288
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    April 10, 2016
    Report Date
    April 10, 2016
    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 PART INVOLVED WITH THIS COMPLAINT. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE. THE PART WAS INSTALLED ONTO AN IN-HOUSE TEST SYSTEM AND FAILED TO POWER ON. THE PART SHOULD MEASURE AT +48 VOLTS BUT WAS FOUND TO MEASURE AT 0 VOLTS. THE POWER SUPPLY WAS FOUND DEFECTIVE. 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) WENT INTO BATTERY MODE. THE CUSTOMER TRIED TO RESOLVE THE ISSUE BY PRESSING THE EMERGENCY POWER OFF (EPO) SWITCH AND RESTARTING THE SYSTEM BUT THE ISSUE PERSISTED. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT CONFIRMED WITH THE CUSTOMER THE POWER OUTLETS WERE WORKING BUT THE SYSTEM WAS STILL RUNNING ON BATTERY MODE AS INDICATED BY THE CHARGING LED ON THE SYSTEM, WHICH REMAINED AMBER. ON (B)(6) 2016, ISI OBTAINED ADDITIONAL INFORMATION FROM THE REPORTER. THERE WAS A DELAY OF 30 MINUTES FOR THE PROCEDURE. SURGICAL PORTS WERE PLACED; HOWEVER, THERE WAS NO REPORT OF ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. DUE TO THE REPORTED ISSUE, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO LAPAROSCOPY. THE PATIENT TOLERATED THE LAPAROSCOPY PROCEDURE WELL. THERE WAS NO REPORT OF PATIENT INJURY OR HARM. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) CONDUCTED ADDITIONAL INVESTIGATION OF THE SYSTEM ON SITE. TFS FOUND THE PSC STARTED UP ON BATTERY MODE ONLY AND THE BATTERY CHARGING DOESN'T WORK. THERE WAS NO POWER ON THE DIRECT CURRENT (DC) OUTPUT OF THE INSTALLED PSC POWER SUPPLY. THE TFS REPLACED THE PSC MEDICAL GRADE POWER SUPPLY (MGPS) TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273567 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1