BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2024247 · Received March 18, 2011

    Report

    Report Number
    2955842-2011-00083
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON, HOWEVER, THE SURGEON HAS BEEN UNAVAILABLE. TO DATE, NO INFORMATION HAS BEEN RECEIVED WHICH SUGGESTS THAT THE DA VINCI SI SURGICAL SYSTEM MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POST SURGICAL COMPLICATIONS. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED, THE PATIENT DEVELOPED A 103 DEGREE FEVER AND THEIR HEART RATE JUMPED TO 130. THE SURGEON PERFORMED A CT SCAN AND A BLOOD CLOT WAS OBSERVED. NO OTHER INFORMATION WAS RECEIVED.

    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

    Patients

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