BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 8011775 · Received October 28, 2018

    Report

    Report Number
    2955842-2018-10624
    Event Type
    Death
    Date Received
    October 28, 2018
    Date of Event
    January 18, 2013
    Report Date
    October 3, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR IS ACTUALLY BEING SUBMITTED AS A FOLLOW-UP #1 MDR REPORT FOR MFR REPORT #2955842-2014-02551 (PATIENT IDENTIFIER (B)(6)). THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR MDR REPORT SUBMISSIONS. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PLAINTIFF¿S ATTORNEY: THE DEATH CERTIFICATE INDICATED THAT THE PATIENT¿S CAUSE OF DEATH WAS ¿SEPSIS¿ DUE TO OR AS A CONSEQUENCE OF ¿ACUTE OR CHRONIC RESPIRATORY FAILURE,¿ DUE TO OR AS A CONSEQUENCE OF ¿FALLOPIAN TUBE DAMAGE,¿ DUE TO OR AS A CONSEQUENCE OF ¿COPD AND OSA.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AND SEPTIC SHOCK, AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 6 WEEKS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED PELVIC ABSCESS IS STILL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852464 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R