BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1760256 · Received July 16, 2010

    Report

    Report Number
    2955842-2010-00325
    Event Type
    Injury
    Date Received
    July 16, 2010
    Report Date
    June 17, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A FAULTY CAMERA CABLE. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON'S CONSOLE. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CAMERA CABLE. THE CAMERA CABLE WAS RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR EVALUATION. THE OEM OBSERVED THAT THE LEFT CHANNEL OF THE CAMERA CABLE HAD A LOOSE CONNECTION, THUS CAUSING THE VISION ISSUE EXPERIENCED BY THE CUSTOMER. 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 BACKUP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE PERFORMED ON (B)(6) 2008, THE SURGEON EXPERIENCED INTERFERENCE IN THE LEFT EYE IMAGE VIEWED FROM THE SURGEON'S CONSOLE. THE SURGEON SWITCHED THE IMAGE FROM 3-DIMENSIONAL (3-D) TO 2-DIMENSIONAL (2-D) TO PROCEED WITH THE PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE CUSTOMER-REPORTED-EVENT DOES NOT IN ITSELF CONSTITUTE A REPORTABLE EVENT, HOWEVER, ON JUNE 17, 2010, ISI RECEIVED A LEGAL SUMMONS AND COMPLAINT FILED BY THE PATIENT, ALLEGING THAT DUE TO THE AMOUNT OF TIME ADDED BY COMPLETING THE SURGERY IN 2-D (THE SURGERY LASTED OVER 8 HOURS) THE PATIENT SUSTAINED A SEVERE AND PERMANENT RIGHT LEG INJURY, SPECIFICALLY RIGHT CALF COMPARTMENT SYNDROME. THE COMPLAINT FURTHER ALLEGES THAT THE PATIENT HAS UNDERGONE NUMEROUS AND EXTENSIVE MEDICAL PROCEDURES, INCLUDING SURGERY AND THERAPY.

    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 A5.1P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES