BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1890381 · Received November 3, 2010

    Report

    Report Number
    2955842-2010-00479
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) FOUND SYSTEM ERROR CODE 23017 TO BE ASSOCIATED WITH A PATIENT SIDE MANIPULATOR (PSM) ARM. 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 23017 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT A MOTOR DID NOT RESPOND AS EXPECTED AND THE MEASURED MOTION DID NOT MATCH THE INTERNAL SIMULATION OF THE MOTOR. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A RECOVERABLE SAFE STATE. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED PROBLEM AND FOUND THE PSM TO HAVE A DEFECTIVE MOTOR/ENCODER ASSEMBLY WHICH WAS REPLACED TO REPAIR THE PSM. AS OF (B)(6) 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE BEGINNING OF A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED SYSTEM ERROR CODE 23017 ON A PATIENT SIDE MANIPULATOR (PSM) ARM. THE SITE RESTARTED THE SYSTEM MULTIPLE TIMES WITHOUT SUCCESS. AT THIS TIME, THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. 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 INSTRUMENT, ACCESSORIES AND ESU