BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1646666 · Received March 26, 2010

    Report

    Report Number
    2955842-2010-00122
    Event Type
    Injury
    Date Received
    March 26, 2010
    Report Date
    February 25, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 18, 2010, THE SURGEON REPORTED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM DURING THE PROCEDURE AND THAT THE INJURY TO THE PATIENT'S RADIAL NERVE WAS DUE TO THE PATIENT'S ARM POSITIONING. THE SURGEON WAS UNABLE TO PROVIDE ANY DETAILS CONCERNING THE DATE THAT THE EVENT OCCURRED OR OTHER PATIENT DETAILS, HOWEVER, THE SURGEON STATED THAT THE PATIENT HAS FULLY RECOVERED AND SUSTAINED NO PERMANENT DAMAGE. AS OF MARCH 18, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A DA VINCI SI THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS DUE TO RADIAL NERVE DAMAGE.

    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 A60.P3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DVSI INSTRUMENTS