BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1915186 · Received December 6, 2010

    Report

    Report Number
    2955842-2010-00524
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FE) WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED SULFUR SMELL. SURGICAL STAFF THEN NOTIFIED THE FE THAT DURING A CASE THE DAY PRIOR TO THIS EVENT, A PATIENT SUFFERED SEVERE DIARRHEA AND THAT THE SMELL WAS LIKELY RELATED TO THIS EVENT. THE FE WAS UNABLE TO FIND ANY PHYSICAL EVIDENCE OR ODOR RESULTING FROM CONTAMINATION OR FLUID INTRUSION TO THE PATIENT SIDE CART. ADDITIONALLY, NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED. AS OF DEC 2, 2010 THE SITE HAS CONTINUED TO PERFORM PROCEDURES WITH THE DA VINCI SI SURGICAL SYSTEM AND THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR A DA VINCI SI PROCEDURE, THE SURGICAL STAFF DETECTED A SULFUR LIKE SMELL COMING FROM THE PATIENT SIDE CART (PSC) IN THE OPERATING ROOM. NO SYSTEM ERRORS WERE REPORTED AND WHEN MOVING THE PSC INTO ANOTHER ROOM, THE ODOR SEEMED TO FOLLOW THE SYSTEM. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULE FOR A LATER DATE.

    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 A6.0P5

    Patients

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