BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 853304 · Received May 18, 2007

    Report

    Report Number
    2955842-2007-00129
    Event Type
    Other
    Date Received
    May 18, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 18, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM FAULT EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ECM. THE ECM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING DISCOVERED THAT A MOTOR ENCODER ASSEMBLY HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERRORS EXPERIENCED BY THE CUSTOMER. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) 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 MAY 18, 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 A RECURRING 23015 SYSTEM ERROR CODE. 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P2 SG118

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention