BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI STANDARD SURGICALSYSTEM

    MDR report key: 2873240 · Received December 13, 2012

    Report

    Report Number
    2955842-2012-01308
    Event Type
    Other
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE REPORTED ISSUES EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH THE CAMERA HEAD. THE CAMERA HEAD PRODUCES THREE DIMENSIONAL IMAGES TO THE DA VINCI STANDARD VISION SYSTEM THROUGH RIGHT AND LEFT OPTICAL PATHS. THE IMAGES ARE THEN ACQUIRED THROUGH SEPARATE OPTICAL CHANNELS OF THE ENDOSCOPE AND ARE DIRECTED TO THE CAMERA HEAD AND PROCESSED INDEPENDENTLY. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CAMERA HEAD. ON (B)(6) 2012 THE CUSTOMER PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IT WAS STATED THAT THE SURGERY WAS PERFORMED WITH OPEN SURGICAL TECHNIQUES, AND THE PATIENT WAS RELEASED FROM THE HOSPITAL. THE PATIENT TOLERATED THE PROCEDURE WELL, HOWEVER, HAD A LONGER HOSPITAL STAY. AS OF (B)(6) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE SAME ISSUE AT THIS HOSPITAL. THE CAMERA HEAD HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION), OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI STANDARD PROSTATECTOMY PROCEDURE, THE CAMERA ICON WAS BLINKING, AS THE CUSTOMER FORGOT TO SELECT AN OPTIC. FIFTEEN MINUTES LATER, THE CUSTOMER CALLED BACK TO REPORT THAT THE FOCUS WAS NOT WORKING FROM THE SURGEON SIDE CONSOLE (SSC). WITH THE ASSISTANCE OF THE TECHNICAL SUPPORT ENGINEER (TSE), THE SURGEON PERFORMED SEVERAL TROUBLESHOOTING STEPS AS DIRECTED. THE REAR SSC CONNECTORS WERE CHECKED, THE FOCUS WAS ACTIVATED FROM THE FOCUS CONTROLLER, THE CAMERA CABLE WAS CHECKED TO BE SURE IT WAS TIGHTENED FROM BOTH ENDS, AND LASTLY, THE CAMERA CABLE WAS REPLACED WITH A NEW ONE. HOWEVER, AS THE SAME PROBLEM PERSISTED, THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. AS RECOMMENDED BY THE ENGINEER, THE CAMERA HEAD WAS REPLACED BY THE HEAD NURSE THE FOLLOWING DAY TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS WORKING AS EXPECTED AFTER THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI STANDARD SURGICALSYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other DA VINCI STD SYSTEM INSTRUMENTS AND ACCESSORIES