BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3183229 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02272
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, ISI CONTACTED THE HOSPITAL'S RISK MANAGER. THE RISK MANAGER INDICATED THAT THERE WAS NO REPORT BY THE SURGICAL STAFF THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO ISSUES NOTED DURING THE SURGICAL PROCEDURE. THE HOSPITAL'S INVESTIGATION IS CURRENTLY ONGOING AND THE ROOT CAUSE OF THE PATIENT'S DEMISE HAS NOT BEEN DETERMINED, AS THE HOSPITAL HAS NOT YET RECEIVED THE FINAL REPORT FROM THE CORONER'S OFFICE. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT'S DEATH, POST-OP A DA VINCI SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS PROVIDED. A REVIEW OF THE SITE'S SYSTEM LOG FOR THE REPORTED PROCEDURE DATE FOUND NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS POST OP A DA VINCI SI ENDOMETRIOSIS RESECTION PROCEDURE, PERFORMED ON (B)(6) 2013, THE PATIENT EXPIRED AT HOME. DURING THE SURGICAL PROCEDURE, EXTENSIVE RESECTION WAS COMPLETED ON THE PATIENT'S LEFT PELVIS SURROUNDING THE URETER AND COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282684 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR DA VINCI SI SYS. , INSTRUMENTS, ACCESSORIES & ES