BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1590511 · Received January 29, 2010

    Report

    Report Number
    2955842-2010-00026
    Event Type
    Other
    Date Received
    January 29, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 8, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE SYSTEM ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) GIMBAL. THE MTM GIMBAL IS A SUBSECTION OF THE COMPLETE MTM ARM, CONSISTING OF THE LINKS ASSOCIATED WITH THE FIVE AXES OF MOTION CLOSEST TO THE SURGEON'S HAND. THESE AXES MEASURE THE ORIENTATION OF THE MTM HANDLE AND THE MTM GRIP ANGLE. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML GIMBAL. THE MTML GIMBAL WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING OBSERVED THAT THE FLEX CABLE HAD BEEN SNAGGED BY SOMEONE/SOMETHING, IS TORN AT ONE END, AND IS HANGING OUTSIDE OF THE GRIP ASSEMBLY. THE DAMAGE THUS RESULTED IN THE SYSTEM ISSUE EXPERIENCED BY THE CUSTOMER. AS OF (B)(6), 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE THE SYSTEM'S LEFT MASTER HAND SENSOR SEPARATED FROM THE GRIP AND THE INSTRUMENT ASSIGNED TO THE LEFT HAND BECAME UNRESPONSIVE. THE SURGICAL STAFF WAS UNABLE TO REASSEMBLE THE LEFT MASTER. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    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 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DV SYSTEM INSTRUMENTS & ACCESSORIES