BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3372024 · Received September 26, 2013

    Report

    Report Number
    2955842-2013-03812
    Event Type
    Other
    Date Received
    September 26, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE SYSTEM LOGS REVEALED THAT THE REPORTED DA VINCI SI SYSTEM WAS USED ON SUBSEQUENT SURGICAL PROCEDURES ON (B)(6) 2013 WITH NO ERRORS. ON (B)(6) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND WAS ABLE TO REPRODUCE THE REPORTED DISPLAY ISSUE. THE FSE NOTED THAT THE CAMERA HEAD'S LIGHT GUIDE ASSEMBLY HAD ABNORMAL WEAR AND TEAR. THE SITE ONLY HAD THE DA VINCI SI SYSTEM FOR LESS THAN 60 DAYS AND THE LOCKING BRACKET WAS ABLE TO GIVE SLACK ENOUGH TO CAUSE THE LIGHT TO CONCENTRATED ON A SPECIFIC EYE WHILE HOLDING THE ENDOSCOPE. THE FSE PERFORMED A MECHANICAL ADJUSTMENT AND TIGHTENED THE CAMERA HEAD'S LIGHT GUIDE ASSEMBLY. THE CUSTOMER AGREED THAT THE PICTURE ON THE VISION CART LOOKED BETTER THAN PREVIOUSLY BEFORE. THE CAMERA HEAD ASSEMBLY WITH LIGHT GUIDE WERE STILL EXCHANGED SINCE THE SYSTEM WAS FAIRLY NEW. THE CUSTOMER INDICATED THAT THEY WERE ONLY EXPERIENCING THE REPORTED ISSUE WHEN USING THE DA VINCI SI ENDOSCOPE FOR A NON-ROBOTIC PROCEDURE WITH THE PATIENT PRIOR TO USING THE DA VINCI SI ROBOTIC SYSTEM. THE CUSTOMER WAS INFORMED THAT THE ENDOSCOPE WAS NOT INTENDED FOR LAPAROSCOPIC USE OTHER THAN THE DA VINCI ROBOTIC PROCEDURES. THE SURGEON CONSOLE VIEW HAD NO DARK RING PRESENT AND WAS VERIFIED TO BE OPERATIONAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DA VINCI SI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AFTER THE SITE HAD IDENTIFIED A DARK SHADOW ON THE VISION CART'S TOUCHSCREEN DISPLAY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SITE CONTACTED INTUITIVE SURGICAL INC. (ISI) AND SPOKE TO A TECHNICAL SERVICE ENGINEER (TSE) TO REPORT A DARK SHADOW AROUND THE EDGE OF THE DA VINCI SI VISION CART'S TOUCHSCREEN AND THE ISSUE WAS ALSO SLIGHTLY LESS NOTICEABLE ON THE SURGEON'S CONSOLE. THE TSE NOTED THAT THE ENDOSCOPE TIP WAS OUT BEYOND THE TIP OF THE CANNULA. THE TSE WALKED THE REPORTER THROUGH DOING A RESTORE FACTORY SETTINGS AT THE VISION CART'S TOUCHSCREEN BUT THE IMAGE DID NOT IMPROVE. THE TSE THEN SUGGESTED THE REPORTER TO PERFORM A WHITE BALANCE CALIBRATION BUT THE SURGEON DECIDED TO CONVERT TO AN OPEN SURGICAL PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE SITE AND SPOKE WITH A NURSE. THE NURSE INDICATED THAT THE PATIENT WAS ALREADY UNDER ANESTHESIA AND THE DA VINCI PORTS WERE ALREADY PLACED; HOWEVER, THE DA VINCI SI SYSTEM WAS NOT DOCKED TO THE PATIENT PRIOR TO THE DECISION TO CONVERT TO OPEN SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487111 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES