BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3854743 · Received June 6, 2014

    Report

    Report Number
    2955842-2014-03490
    Event Type
    Death
    Date Received
    June 6, 2014
    Report Date
    April 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S INJURY AND SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AN ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI HYSTERECTOMY PROCEDURE AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME THE CAUSE OF THE PATIENT'S INJURY AND SUBSEQUENT DEMISE ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY CONVERTED TO AN OPEN TRANSABDOMINAL HYSTERECTOMY FOR INFUNDIBULAR PELVIC VENOUS BLEEDING ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL/LEGAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. ON (B)(6) 2013, THE PATIENT ARRIVED FOR SURGERY ACUTELY INTOXICATED. THE SURGERIES WERE RESCHEDULED. PER THE OPERATIVE REPORT, AT COMPLETION OF ROBOTIC PROCEDURE, THERE WAS NOTED TO BE BLEEDING OF THE LEFT INFUNDIBULOPELVIC LIGAMENT, WHICH WAS UNCONTROLLABLE, REQUIRING CONVERSION TO LAPAROTOMY AND ASSISTANCE TO CONTROL THE BLEEDING. AN ON-CALL TRAUMA SURGEON WAS CONSULTED INTRAOPERATIVELY FOR EVALUATION OF A HEMORRHAGIC CYST THAT HAD BEEN REMOVED AND IP INFUNDIBULUM PELVIC VENOUS BLEEDING ON THE RIGHT AND THEN MARGINALLY ON THE LEFT. THE ON-CALL TRAUMA SURGEON NOTED, THE VENOUS BLEEDING WAS SIGNIFICANT IN CONJUNCTION WITH HER COAGULOPATHY. OOZING VESSELS WERE TIED OFF WITH SUTURES. THE PATIENT RECEIVED BLOOD TRANSFUSION. THE ESTIMATED BLOOD LOSS FROM THE PROCEDURE WAS 1000 ML. SURGICAL FINDINGS INCLUDED A HEMORRHAGIC OVARIAN CYST ON RIGHT WITH ATTACHED IP VESSELS, ALCOHOLIC CIRRHOSIS OF THE LIVER, AN ENLARGED GALLBLADDER, AND TISSUE EXTREMELY SOFT AND FRIABLE, ESPECIALLY IN THE ENTIRE BODY AND FUNDUS OF THE UTERUS. THE PATIENT WAS TRANSFERRED TO THE ICU INTUBATED. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPECTED TO BE IN DELIRIUM TREMENS AND MEDICATION AND SLOW EXTUBATION WAS NECESSARY TO CONTROL THE SIDE EFFECTS OF ALCOHOLISM. THE POSTOPERATIVE COURSE WAS COMPLICATED BY RESPIRATORY FAILURE, ACUTE RESPIRATORY DISTRESS SYNDROME, LIVER FAILURE WITH JAUNDICE, SEPSIS, HYPOTENSION, REFRACTORY SHOCK, ACUTE CHOLECYSTITIS, COAGULOPATHY, ANEMIA, HYPOTENSION, ALCOHOL WITHDRAWAL, DIARRHEA, PULMONARY EDEMA, ELECTROLYTE IMBALANCE, METABOLIC ACIDOSIS, AND HYPERBILIRUBINEMIA. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, CHOLECYSTOSTOMY, FEEDING JEJUNOSTOMY, AND TRACHEOSTOMY PERFORMED FOR SEPSIS, JAUNDICE, CHOLECYSTITIS, AND CHOLELITHIASIS. SURGICAL FINDINGS INCLUDED EXCESSIVE HEPATIC BLEEDING WITH A NON-MOBILE LIVER STILL AND ENLARGED. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS TAKEN TO THE ICU IN CRITICAL CONDITION. ON (B)(6) 2013, THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL CENTER FOR A HIGHER LEVEL OF CARE. PER THE DISCHARGE SUMMARY, HER JAUNDICE WAS MOST LIKELY FELT TO BE SECONDARY TO CHOLESTASIS AND LIVER FAILURE AS THE RESULT OF BLOOD TRANSFUSION, ISCHEMIA AND UNDERLYING ALCOHOLIC HEPATITIS AT BASELINE. THE CHOLECYSTOSTOMY TUBE AND MORISON'S POUCH APPEARED TO BE DRAINING BILIOUS FLUID CONSISTENT WITH A POSSIBLE LEAKING GALLBLADDER WALL. THE PATIENT WAS NOTED TO BE CRITICALLY ILL, ON A VENTILATOR, SEDATED, AND JAUNDICED. AT THE NEW MEDICAL CENTER, THE PATIENT CONTINUED TO RECEIVE ICU TREATMENT FOR ARDS, RENAL FAILURE, ASCITES, AND SEVERE PROTEIN-CALORIE MALNUTRITION. THE PATIENT DID NOT IMPROVE AND REMAINED UNRESPONSIVE. THE PATIENT'S FAMILY ULTIMATELY DECIDED FOR COMFORT CARE. THE PATIENT WAS TAKEN OFF THE VENTILATOR AND PLACED ON COMFORT CARE ON (B)(6) 2013. THE PATIENT EXPIRED ON (B)(6) 2013. ON (B)(6) 2013, PER THE DISCHARGE SUMMARY, THE PRINCIPAL DIAGNOSIS WAS NOTED TO BE SEPTIC SHOCK. SECONDARY DIAGNOSES INCLUDED: VENTILATOR-DEPENDENT RESPIRATORY FAILURE, ADULT RESPIRATORY DISTRESS SYNDROME, HEPATIC FAILURE, ACUTE RENAL FAILURE, GASTROINTESTINAL BLEED, HYPERURICEMIA, HYPERTENSION, HYPERBILIRUBINEMIA, ASCITES, IRON DEFICIENCY ANEMIA, CHRONIC ALCOHOL ABUSE, SEVERE ENCEPHALOPATHY, AND HISTORY OF LEIOMYOMA OF UTERUS. PER THE DEATH CERTIFICATE, THE DATE OF DEATH WAS (B)(6) 2013. THE IMMEDIATE CAUSE OF DEATH WAS SEPTIC SHOCK SECONDARY TO UNKNOWN SOURCE; ACUTE RENAL FAILURE DUE TO SEPTIC SHOCK; MENORRHAGIA DUE TO LEIOMYOMA. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS FROM AN UNKNOWN SOURCE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI HYSTERECTOMY AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331308 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death