BEUDAMED
    FDA Adverse Event Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2200416 · Received August 11, 2011

    Report

    Report Number
    2955842-2011-00263
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING COULD NOT REPRODUCE THE STERILE ADAPTER ISSUE. THE SYSTEM WAS EVALUATED FOR ANY POTENTIAL ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS ISSUE, HOWEVER, THE SYSTEM WAS FOUND TO BE OPERATING WITHIN SPECIFICATION WITH NO MALFUNCTIONS OBSERVED. AS OF (B)(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 SI CYSTECTOMY PROCEDURE, THE SITE EXPERIENCED TROUBLE ENGAGING THE STERILE ADAPTER ON THE SYSTEM'S PATIENT SIDE MANIPULATOR (PSM). WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE ATTEMPTED TO ENGAGE THE STERILE ADAPTER SEVERAL TIMES BEFORE THE STERILE ADAPTER WAS SUCCESSFULLY ENGAGED. THE SITE CONTINUED ON WITH THE PROCEDURE; HOWEVER, THE ISSUE REOCCURRED. WITH THE ASSISTANCE OF A TSE, THE SITE PERFORMED AN EMERGENCY STOP AND FAULT OVERRIDE WITHOUT SUCCESS. THE SURGEON 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 SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

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