BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1724831 · Received May 28, 2010

    Report

    Report Number
    2955842-2010-00216
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 29, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED BY THE ATTENDING SURGEON ON MAY 4 & 20, 2010, 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 MAY 27, 2010, NO ADVERSE EVENTS OR SYS MALFUNCTIONS HAVE BEEN EXPERIENCED WITH THE SITE'S DA VINCI S SURGICAL SYS AND NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO ISI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WHO UNDERWENT A DA VINCI S TORS PROCEDURE ON (B) (6), 2010, EXPIRED ON (B) (6), 2010. ON MAY 4, 2010, THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE INFORMED ISI THAT THERE WERE NO ACUTE COMPLICATIONS WITH THE CASE AND THE PT WAS DISCHARGED 4-5 DAYS AFTER THE PROCEDURE WAS PERFORMED. THE SURGEON ALSO MENTIONED THAT FOLLOW-UP WAS CONDUCTED WITH THE PT APPROX ONE WEEK AFTER THE OPERATION AND THE PT WAS FOUND TO BE DOING WELL. SHORTLY AFTER, THE PT BEGAN EXPERIENCING POST-OPERATIVE BLEEDING AND PASSED AWAY. THE SURGEON INDICATED THAT HE DOES NOT BELIEVE THAT THE ROBOTIC PROCEDURE WAS THE DIRECT CAUSE OF THIS UNFORTUNATE EVENT, BUT RATHER THIS IS THE TYPE OF COMPLICATION THAT IT ASSOCIATED WITH THESE TYPE OF SURGICAL PROCEDURES. ON MAY 20, 2010, THE SURGEON INDICATED THAT THEY DO NOT HAVE ACCESS TO THE PT'S DEATH CERTIFICATE OR THE HOSPITAL RECORDS FROM THE INSTITUTION THAT THE PT WAS TAKEN TO ON (B) (6), 2010. ADDITIONALLY, THE PT'S FAMILY INFORMED THE SURGEON VIA TELEPHONE THAT THEY DID NOT SEEK AN AUTOPSY.

    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 64 YR Death ACCESSORIES| DA VINCI S SYSTEM INSTRUMENTS