BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3276828 · Received August 9, 2013

    Report

    Report Number
    2955842-2013-02996
    Event Type
    Death
    Date Received
    August 9, 2013
    Date of Event
    September 28, 2010
    Report Date
    July 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (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) 2010. NO SYSTEM FAULTS/ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT CLAIMS THAT THE PATIENT UNDERWENT A DA VINCI SI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS AND A PUNCTURED BOWEL. AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AND INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IT IS ALSO UNKNOWN IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY AND SUBSEQUENT DEMISE.

    Additional Manufacturer Narrative · 1

    ON 05/27/2014, INTUITIVE SURGICAL, INC. (ISI) IDENTIFIED THAT THIS MDR IS A DUPLICATE REPORT OF PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2014-01020. WHEN THE INITIAL MDR FOR PATIENT IDENTIFIER = (B)(6) WAS SUBMITTED ON (B)(4) 2014, IT WAS UNKNOWN THAT BOTH MDR'S INVOLVED THE SAME PATIENT AND REPORTED EVENT. THIS MDR (MFR REPORT 2955842-2013-02996) IS BEING RETRACTED AS A DUPLICATE MDR OF PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2014-01020.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT IN THE IMMEDIATE DAYS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF SEVERE ABDOMINAL PAIN AND EXTREME DISTENSION OF ABDOMEN, TROUBLE STANDING OR WALKING, DIFFICULTY BREATHING, LACK OF BOWEL MOVEMENTS AND FLATUS, AND BLACK FOUL SMELLING EMESIS. THE LEGAL COMPLAINT ALSO INDICATED THAT ON (B)(6) 2010, THE PATIENT WAS TRANSPORTED TO A HOSPITAL VIA AMBULANCE AND ADMITTED FOR SEVERE ABDOMINAL SEPSIS AND INFLAMMATION OF THE ABDOMEN AND ABDOMINAL TISSUE. IN ADDITION, THE PATIENT WAS OPERATED ON IMMEDIATELY AFTER ADMITTANCE TO THE HOSPITAL. ACCORDING TO THE LEGAL COMPLAINT, DURING THE OPERATION, DOCTORS OBSERVED THE PATIENT WAS SEPTIC AND HAD A PUNCTURED COLON. THE PATIENT WAS KEPT IN THE INTENSIVE CARE UNIT (ICU) IN SEVERE CRITICAL CONDITION MAINTAINED BY A VENTILATOR, SO THAT THE DOCTORS COULD CONTINUE TO TREAT HER. ALSO, THE LEGAL COMPLAINT INDICATED THAT DESPITE INVASIVE MEDICAL PROCEDURES EVERY TWO DAYS OVER THE DURATION OF TWO WEEKS IN ATTEMPT TO TREAT THE PATIENT, THE SEPSIS WAS TOO ADVANCED AND IRREVERSIBLE. THE LEGAL COMPLAINT CLAIMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2010, DUE TO SEPSIS AND HYPOTENSION CAUSED BY A PUNCTURED COLON FROM THE DA VINCI SURGICAL SYSTEM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377609 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES