BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2193027 · Received August 5, 2011

    Report

    Report Number
    2955842-2011-00253
    Event Type
    Other
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI FIELD SERVICE ENGINEERING PROVIDED THE SITE ADDITIONAL TRAINING ON HOW TO REPLACE THE ECM CANNULA MOUNT AND THE PART NUMBER TO OBTAIN SPARES FOR THEIR INVENTORY. THE ECM IS THE CAMERA ARM LOCATED ON THE PATIENT SIDE CART WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE CANNULA MOUNT ACCESSORY IS ATTACHED TO THE ECM AND DESIGNED TO HOLD THE CANNULA SECURELY IN PLACE, OUTSIDE OF THE PATIENT CAVITY. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ECM CANNULA MOUNT ACCESSORY. THE DA VINCI S SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT: ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI S SYSTEM TO BECOME UNAVAILABLE. THE SURGICAL TEAM SHOULD ALWAYS HAVE BACK UP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES. AS OF (B)(4) 2011 THERE HAVE BEEN NO REPORTED RECURRENCES OD THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING TO BEGIN A DA VINCI S PROSTATECTOMY PROCEDURE, THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) CANNULA MOUNT BROKE AT THE BASE CONNECTION POINT INTO THE ECM. THE PATIENT SIDE CART WAS DOCKED TO THE PATIENT AND THE CAMERA WAS BEING INSERTED INTO THE ECM WHEN THE CANNULA MOUNT BROKE. THE SITE DID NOT HAVE A SPARE ECM CANNULA MOUNT. THE PATIENT WAS UNDER ANESTHESIA AND THE PORT INCISIONS WERE MADE WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AND RESCHEDULE FOR A LATER DATE. 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 A5.1P8

    Patients

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