BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2589305 · Received May 25, 2012

    Report

    Report Number
    2955842-2012-00235
    Event Type
    Death
    Date Received
    May 25, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K060391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYSTEM LOGS SHOWED THAT NO SYSTEM FAULTS OCCURRED DURING SURGERY. THERE WAS NO REPORT OF SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTION RELATED TO THIS PROCEDURE. THE ROOT CAUSE OF DEATH IS THOUGHT TO BE EITHER INTUBATION OR THE RESULT OF BLEEDING. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE ACCOUNT WERE MADE. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF MAY 25, 2012, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, MINOR BLEEDING OCCURRED. THE BLEEDING WAS REGARDED AS NORMAL BLEEDING FROM MINOR VESSELS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WENT INTO RECOVERY. THE PATIENT SEEMED FINE DURING RECOVERY; HOWEVER, AT AN UNKNOWN TIME AFTER THE SURGERY, THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS PROVIDED.

    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 Death DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES