BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1230293 · Received November 7, 2008

    Report

    Report Number
    2955842-2008-01360
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 7, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS- THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING WAS UNABLE TO CONFIRM THE UNRESPONSIVE PSM ISSUE REPORTED BY THE CUSTOMER. SYSTEM ERROR CODE #21003 IS ASSOCIATED WITH A PT SIDE MANIPULATOR (PSM) ARM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. THE #21003 SYSTEM ERROR CODE APPEARS WHEN THE DA VINCI SAFETY SYSTEM DETECTS THAT A SYSTEM ARM WAS "BUMPED" OR RESTRICTED FROM MOVING PROPERLY DURING STARTUP. UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEMS PUT DA VINCI IN A "RECOVERABLE SAFE STATE". AS OF (B) (6), 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE ONE OF THE PT'S SIDE MANIPULATOR (PSM) ARMS WOULD NOT RESPOND AND THE FAULT OVER-RIDE LIGHT WAS ILLUMINATED. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER THE SYSTEM ERROR LOGS WERE RETRIEVED AND SYSTEM ERROR #21003 WAS FOUND. THE CUSTOMER TRIED TO ENGAGE AN INSTRUMENT HOWEVER, THE ENGAGEMENT ISSUE CONTINUED TO OCCUR. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE 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 DA VINCI SURGICAL SYSTEM| INSTRUMENTS| ACCESSORIES.