BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1953007 · Received January 7, 2011

    Report

    Report Number
    2955842-2011-00007
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K060391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) FOUND THE INSTRUMENT ENGAGEMENT ISSUE REPORTED BY THE CUSTOMER WAS ASSOCIATED WITH THE RIGHT SPRING PLUNGER ON THE AFFECTED PATIENT SIDE MANIPULATOR (PSM) ARM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SPRING PLUNGERS ARE MECHANICAL ELEMENTS USED TO HELP SECURE AND POSITION THE STERILE ADAPTER INTERFACE BETWEEN THE PSM AND THE STERILE INSTRUMENT. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED PROBLEM AND FOUND ONE OF THE PSM'S SPRING PLUNGERS, BETWEEN AXIS 4-7 ON TOP OF LINK 6, TO BE BENT AND DIFFICULT TO DEPRESS. THE 4 AFFECTED SPRING PLUNGERS WERE REPLACED. AS OF JANUARY 6, 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 S MITRAL VALVE REPLACEMENT PROCEDURE, AN INSTRUMENT BECAME STUCK ON A PATIENT SIDE MANIPULATOR (PSM) ARM. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE PSM WAS UNDOCKED FROM THE PATIENT AND THE CANNULA AND INSTRUMENT WERE REMOVED. THE PSM WAS RE-DRAPED AND THE SITE ATTEMPTED TO RE-ENGAGE A DIFFERENT INSTRUMENT ON THE ARM, HOWEVER, THE ENGAGEMENT PROBLEM CONTINUED TO OCCUR. THE SURGEON MADE THE DECISION 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 S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

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