BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 874133 · Received June 28, 2007

    Report

    Report Number
    2955842-2007-00187
    Event Type
    Other
    Date Received
    June 28, 2007
    Date of Event
    May 29, 2007
    Report Date
    June 26, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM FAULTS EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH A REMOTE INTERFACE ADAPTOR (RIA) PCA. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RIA PCA. 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 JUNE 26, 2007, 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 "POWER FLUCTUATION" ERRORS. 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P8 S00233

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other ACCESSORIES AND UNKNOWN ELECTROSURGICAL UNIT| ISI INSTRUMENTS