BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1235695 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01367
    Event Type
    Other
    Date Received
    November 14, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY A FIELD SVC ENGINEER FOUND A CABLE BROKEN ON THE PT SIDE MANIPULATOR (PSM), CAUSING AN AXIS TO SPIN FREELY. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE SYSTEM ERROR CODES APPEARED WHEN THE REDUNDANT SENSORS IN THE SPECIFIED MANIPULATOR MEASURED DIFFERENT VALUES FOR THE ANGULAR POSITION (RESULTING IN SYSTEM ERROR CODE #20008) OR THE RATE OF CHANGE IN ANGULAR POSITION (RESULTING IN SYSTEM ERROR CODE #20013). UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUT THE DA VINCI IN A "RECOVERABLE SAFE STATE." ENGINEERING CONFIRMED THE PSM AXIS-7 CABLE WAS DERAILED, CAUSING THE CUSTOMER REPORTED PROBLEM. THE SYSTEM WAS REPAIRED BY REPLACING ALL AXIS-7 CABLES AS A PRECAUTIONARY MEASURE. AS OF (B)(4), 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX ONE HOUR INTO A DA VINCI PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED MULTIPLE #20013 SYSTEM ERROR CODES. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND WITH THE ERROR CODES INDICATING WHICH SYSTEM PT SIDE MANIPULATOR (PSM) WAS FAULTING, THE TSE HAD THE CUSTOMER REMOVE THE STERILE ADAPTER FROM THE PSM, EXERCISE PSM AXIS-7 AND PRESS FAULT OVERRIDE, HOWEVER, THE #20008 AND #20013 SYSTEM ERROR CODES RECURRED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED PROCEDURE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| INSTRUMENTS| DA VINCI SURGICAL SYSTEM