BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3639104 · Received February 21, 2014

    Report

    Report Number
    2955842-2014-01036
    Event Type
    Death
    Date Received
    February 21, 2014
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEATH. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012 AND WAS UNABLE TO LOCATE A HYSTERECTOMY PROCEDURE COMPLETED ON THIS DATE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER THE LEGAL DOCUMENT THE PATIENT DIED AFTER UNDERGOING A DA VINCI PROCEDURE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY DURING THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF FEVER, DIARRHEA, NAUSEA, AND VOMITING. THE PATIENT WAS ADMITTED AND HAD A URINARY TRACT INFECTION AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT 12:04. RESUSCITATION EFFORTS WERE MADE AND THE PATIENT WAS PRONOUNCED DEAD AT 12:34; SHE WAS IN ASYSTOLE AND PULSELESS ELECTRICAL ACTIVITY (PEA) AT THE TIME. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT INDICATE THAT THE PATIENT UNDERGOING THE DA VINCI HYSTERECTOMY PROCEDURE WAS A MALE PATIENT. THE LEGAL DOCUMENT ALLEGES THAT AS A RESULT OF THE DA VINCI PROCEDURE THE PATIENT SUBSEQUENTLY DIED. THE DATE OF DEATH WAS NOT PROVIDED TO INTUITIVE SURGICAL INC. (ISI). NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110555 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death