BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1724830 · Received May 28, 2010

    Report

    Report Number
    2955842-2010-00217
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED BY THE ATTENDING SURGEON, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED, NO SYS MALFUNCTION OCCURRED AND THE SYS DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEMISE. THE HOSP HAS CONTINUED TO USE THE SYS TO PERFORM SURGERY ON PTS. AS OF (B) (6), 2010, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI S SURGICAL SYS AND NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO ISI. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE PT AUTOPSY REPORT IS REC'D FROM THE SITE/SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B) (6), 2010, PASSED AWAY ON (B) (6), 2010. THE ATTENDING SURGEON INDICATED THAT THE SURGICAL PROCEDURE WENT WELL AND THERE WERE NO SYS MALFUNCTIONS. POSTOPERATIVELY, THE PT'S ABDOMINAL PAIN WAS MINIMAL AND HER VITAL SIGNS WERE STABLE, HOWEVER, SHE HAD A SEVERE MIGRAINE HEADACHE THE MORNING OF HER DISCHARGE. THE PT DECLINED MEDICATION FOR HER HEADACHE AND WAS DISCHARGED ON (B) (6), 2010. LATER THAT EVENING, THE PT COMPLAINED OF FATIGUE AND BECAME UNCONSCIOUS. THE PT EXPIRED THE FOLLOWING DAY. ON (B) (6), 2010, THE SURGEON ALSO INDICATED THAT THE AUTOPSY WAS NOT YET COMPLETE AND ISI WILL BE FORWARDED A COPY OF THE AUTOPSY REPORT WHEN IT BECOMES AVAILABLE.

    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 43 YR Death ACCESSORIES| DA VINCI S SYSTEM INSTRUMENTS