BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3428401 · Received October 24, 2013

    Report

    Report Number
    2955842-2013-04608
    Event Type
    Other
    Date Received
    October 24, 2013
    Date of Event
    September 24, 2013
    Report Date
    September 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, AN INTUITIVE SURGICAL INC. FIELD ENGINEER (FE) WENT ON SITE. THE FE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE DA VINCI S SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. NO PARTS WERE REPLACED. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE DA VINCI S SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AFTER THE SITE ENCOUNTERED AN ISSUE WITH THE CAMERA MANIPULATOR ARM.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SITE CONTACTED INTUITIVE SURGICAL INC. (ISI) TO REPORT AN UNEXPECTED SETUP JOINT MOVEMENT WITH THE CAMERA ARM ON THE DA VINCI S PATIENT SIDE CART. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE SITE TO PRESS AND RELEASE THE CAMERA ARM'S PORT CLUTCH BUTTON; HOWEVER, IT IS NOT KNOWN IF THE SITE PERFORMED THIS STEP. THE CALLER THEN REPORTED THAT THE SURGEON HAD DECIDED TO CONVERT THE DA VINCI S PULMONARY LOBECTOMY PROCEDURE TO AN OPEN SURGICAL PROCEDURE AND THEN ENDED THE CALL. ISI ATTEMPTED TO CONTACT THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. BASED ON THE PROVIDED INFORMATION, IT IS NOT KNOWN IF THE PATIENT WAS DOCKED TO THE DA VINCI SYSTEM AT THE TIME THE ISSUE OCCURRED. IT IS ALSO NOT KNOWN WHY THE SURGEON DECIDED TO CONVERT TO AN OPEN SURGICAL PROCEDURE. THE DATE OF THE PROCEDURE WAS NOT VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546489 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000, A5.1P8

    Patients

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