BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 781234 · Received November 10, 2006

    Report

    Report Number
    2955842-2006-00127
    Event Type
    Other
    Date Received
    November 10, 2006
    Date of Event
    September 28, 2006
    Report Date
    September 28, 2006
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTMR. THE MTMR WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING DISCOVERED EXCESSIVE JITTER NOISE EMANATING FROM A POTENTIOMETER ASSEMBLY WITHIN THE MTMR, WHICH CONSEQUENTLY GENERATED THE SYSTEM ERROR EXPERIENCED BY THE CUSTOMER. THE SYSTEM ALARM (20008 SYSTEM ERROR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED A NONRECOVERABLE 20008 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 SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM GEI INTUITIVE SURGICAL, INC. IS1200 A4. 3P5 S00324

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other