BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1623351 · Received March 5, 2010

    Report

    Report Number
    2955842-2010-00089
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    February 16, 2010
    Report Date
    February 16, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONFIRMED ONE PATIENT SIDE MANIPULATOR (PSM) ARM HAD BROKEN CABLES AND CONCLUDED THAT THE SYSTEM ERROR CODE 20008 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THIS PHYSICAL DAMAGE. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 20008 APPEARS WHEN THE DA VINCI SAFETY SYSTEM DETERMINES THAT THE ANGULAR POSITION OF ONE OR MORE ROBOTIC JOINTS ON THE SPECIFIED MANIPULATOR, AS MEASURED BY THAT JOINT'S PRIMARY CONTROL SENSOR (ENCODER) AND THE SECONDARY SENSOR (POTENTIOMETER), WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUTS DA VINCI IN A RECOVERABLE SAFE STATE. THE PSM WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING FOUND THE AXIS 7 CABLES TO BE DAMAGED, THUS GENERATING THE SYSTEM ERROR CODE EXPERIENCED BY THE CUSTOMER. AS MARCH 4, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A DA VINCI SURGICAL PROCEDURE, THE SITE WAS UNABLE TO MOVE A PATIENT SIDE MANIPULATOR (PSM) ARM AND INSTRUMENTS WERE NOT BEING RECOGNIZED WHEN INSTALLED ON THE ARM. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THAT THE CUSTOMER CHECK THE DRAPE AND RESEAT THE INSTRUMENT STERILE ADAPTER ON THE SUSPECT PSM, HOWEVER, THE CUSTOMER STATED THEY WERE USING THE PSM AND WOULD ATTEMPT THESE STEPS WHEN CHANGING THE INSTRUMENT. THE SITE CALLED BACK APPROXIMATELY 10 MINUTES LATER AND STATED THEY WERE GETTING NONRECOVERABLE SYSTEM ERROR CODE 20008. UPON INSPECTION, THE SITE FOUND BROKEN CABLES ON THE SUSPECT PSM. AT THIS TIME, THE SURGEON DECIDED TO ABORT THE PLANNED SURGICAL PROCEDURE. NO PATIENT 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. IS2000 A4.3P9

    Patients

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