BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1760065 · Received July 16, 2010

    Report

    Report Number
    2955842-2010-00319
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 21, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K063220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT WOULD CAUSE NOR CONTRIBUTE TO THE PATIENT INJURY. IT IS UNDETERMINED IF USE ERROR WAS A CONTRIBUTING FACTOR TO THIS EVENT AS PER THE SURGEON, IT IS POSSIBLE THAT HE UNKNOWINGLY NICKED THE PATIENT'S ILLIAC ARTERY DURING THE PROCEDURE. ON (B)(6) 2010, THE SURGEON REPORTED THAT THE PATIENT IS RECOVERING WELL WITH NO FURTHER COMPLICATIONS. AS OF JULY 16, 2010, NO ADVERSE EVENTS OR SYSTEM MALFUNCTIONS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI S SURGICAL SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED A HIGHER THAN NORMAL BLOOD LOSS REQUIRING A BLOOD TRANSFUSION. THE PATIENT WAS REPORTED AS BEING STABLE WHEN THE SURGICAL STAFF MADE THE DECISION TO CONTINUE WITH THE PROCEDURE WITHOUT INCIDENT. ONE DAY POST OPERATION, THE PATIENT WAS OBSERVED TO HAVE INTERNAL BLEEDING AND WAS BROUGHT IN THE OPERATING ROOM WHERE IT WAS DETERMINED THAT HER ILIAC ARTERY HAD BEEN NICKED. THE SURGICAL STAFF CONTROLLED THE BLEEDING BY PACKING THE AFFECTED AREA AND KEEPING THE PATIENT OVER THE WEEKEND. TWO DAYS LATER THE BLEEDING WAS FOUND TO BE UNDER CONTROL AND THE PACKING WAS REMOVED. NO ADDITIONAL PATIENT INJURY OR ADVERSE EVENT HAS BEEN REPORTED. THE SURGEON HAS REPORTED THAT THE PATIENT IS DOING WELL WITH NO FURTHER ISSUES.

    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 Hospitalization| L DA VINCI S SYS, INSTRUMENTS AND ACCESSORIES