BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2823405 · Received November 7, 2012

    Report

    Report Number
    2955842-2012-00831
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. THE SYSTEM TESTED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS. THE FSE CONCLUDED THE SITE'S DA VINCI S SYSTEM ISSUE WITH NON-INTUITIVE MOTION OF THE INSTRUMENT WRIST EXPERIENCED BY THE SURGEON WAS DUE TO THE STERILE ADAPTER NOT BEING PROPERLY ENGAGED. THE PATIENT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). NO PARTS WERE REPLACED TO RESOLVE THE ISSUE, HOWEVER, TRAINING WAS PERFORMED TO AVOID FUTURE OCCURRENCES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOVEMENT OF THE INSTRUMENT WRIST WHILE ARTICULATING THE MASTER TOOL MANIPULATORS FROM THE SURGEON SIDE CART. UNABLE TO RESOLVE THE ISSUE AND PRIOR TO CONTACTING ISI TECHNICAL SUPPORT, THE SURGEON MADE THE DECISION TO ABORT THE PLANNED PROCEDURE AFTER PORT HAD BEEN PLACED AND ANESTHESIA ADMINSTERED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P7

    Patients

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