BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 736024 · Received June 29, 2006

    Report

    Report Number
    2955842-2006-00065
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    May 31, 2006
    Report Date
    May 31, 2006
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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 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 FOUND BROKEN CLAMP SCREWS ON TWO OF THE AXIS GEAR ASSEMBLIES, THUS GENERATING THE SYSTEM FAULTS EXPERIENCED BY THE CUSTOMER. THE SYSTEM ALARMS (THE 20008 AND 21008 SYSTEM ERROR CODES) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER EXPERIENCED RECURRING 20008 AND 21008 FAULTS DURING THE SURGICAL PROCEDURE. NO PT 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 KOG INTUITIVE SURGICAL, INC. IS1200 A4.3P5 S00372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other