BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1979115 · Received February 4, 2011

    Report

    Report Number
    2955842-2011-00036
    Event Type
    Other
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) FOUND THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A 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 SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE, HOWEVER, FOUND THE PSM WRIST INPUT ASSEMBLY TO BE BELOW SPECIFICATION. ALL FOUR WRIST ASSEMBLIES AND THE CANNULA MOUNT 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 APPROXIMATELY 45 MINUTES DURING A DA VINCI SI PULMONARY LOBECTOMY PROCEDURE, AN INSTRUMENT COULD NOT BE RECOGNIZED ON A PATIENT SIDE MANIPULATOR (PSM) ARM. 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 SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYS, INSTRUMENTS AND ACCESSORIES