BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGCAL SYSTEM

    MDR report key: 1977151 · Received February 2, 2011

    Report

    Report Number
    2955842-2011-00033
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING 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 GIMBAL IS SEPARATED FROM THE REST OF THE MTM BY REMOVING THE PLATFORM LINK FROM THE FOREARM LINK. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML GIMBAL. THE MTML GIMBAL WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION OF THE MTML GIMBAL FOUND THE GIMBAL GRIP LEVERS HAD EXCESSIVE PLAY, THUS CONFIRMING THE REPORTED COMPLAINT EXPERIENCED BY THE CUSTOMER. THE GIMBAL GRIP LEVERS WERE REPLACED. AS OF (B)(4), 2011, 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 SACROCOLPOPEXY PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY WITH THE GRIPS OPENING AND CLOSING FOR THE INSTRUMENTS CONTROLLED BY THE LEFT MASTER TOOL MANIPULATOR (MTM). THE PATIENT HAD BEEN UNDER ANESTHESIA FOR APPROXIMATELY ONE HOUR AND 45 MINUTES WHEN THE SURGEON DECIDED TO CONVERT TO 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 SURGCAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES