BEUDAMED
    FDA Adverse Event Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2210818 · Received August 12, 2011

    Report

    Report Number
    2955842-2011-00268
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K063220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY TSE COULD NOT REPRODUCE THE CUSTOMER REPORTED ISSUE. THE TSE CONTACTED THE SURGICAL STAFF AFTER THE PROCEDURE TO DISCUSS THE EVENT. THE STAFF RECYCLED POWER TO THE UNIT AND THE SYSTEM ISSUE WAS RESOLVED. ADDITIONAL TESTING PERFORMED BY THE STAFF DID NOT REVEAL ANY SYSTEM ERRORS OR PROBLEMS WITH THE SYSTEM. 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 S SACROCOLPOPEXY PROCEDURE, THE SITE EXPERIENCED DIFFICULTY IN MOVING A PATIENT SIDE MANIPULATORY (PSM) ARM. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE RESEATED THE STERILE ADAPTOR; HOWEVER, THE SYSTEM DID NOT PUT THE INSTRUMENT AUTOMATICALLY IN FOLLOWING MODE. THE SURGICAL STAFF DECIDED NOT TO CONTINUE WITH TROUBLESHOOTING THE REPORTED PROBLEM AND CONVERTED 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 SI SYSTEM INSTRUMENTS AND ACCESSORIES