BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURIGICAL SYSTEM

    MDR report key: 776267 · Received October 27, 2006

    Report

    Report Number
    2955842-2006-00119
    Event Type
    Other
    Date Received
    October 27, 2006
    Date of Event
    September 27, 2006
    Report Date
    September 27, 2006
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM FAULTS EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH THE PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. BASED ON THE SYSTEM LOGS, THE MOTOR ENCODER ASSEMBLIES AND POTENTIOMETERS WERE REPLACED. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODES) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. AS OF OCTOBER 27, 2006, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED MULTIPLE SYSTEM ERROR CODES WHICH COULD NOT BE OVERRIDDEN. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURIGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM KOG INTUITIVE SURGICAL, INC. IS2000 A5.0P5 SG041

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other