BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4238464 · Received November 7, 2014

    Report

    Report Number
    2955842-2014-05634
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    February 15, 2010
    Report Date
    October 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2010. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A LAPAROSCOPIC SUBTOTAL COLECTOMY WITH ILEOSIGMOID ANASTOMOSIS WITH DA VINCI-ASSISTED MOBILIZATION OF THE DISTAL SIGMOID DUE TO UNRESECTABLE, PREMALIGNANT TRANSVERSE COLON POLYPS AND CHRONIC CONSTIPATION ON (B)(6) 2010. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, AFTER TROCAR PLACEMENT WAS PERFORMED, THE SURGEON NOTED THAT THE ROBOT WAS NOT AVAILABLE FOR USE. ONCE THE ENTIRE SMALL BOWEL, CECUM, HEPATIC, TRANSVERSE, SPLENIC, AND DESCENDING COLON WERE MOBILIZED LAPAROSCOPICALLY, THE ROBOT WAS DOCKED FROM THE LEFT SIDE AND THE REST OF THE SIGMOID WAS MOBILIZED DOWN TO THE LEVEL OF THE PELVIC BRIM. THE SURGEON NOTED THAT THE LEFT URETER WAS IDENTIFIED AND KEPT OUT OF HARMS WAY. THE ROBOT WAS THEN UNDOCKED. THE SURGEON NOTED THE TOTAL ROBOT TIME WAS LESS THAN 10 MINUTES. THE PROCEDURE CONTINUED WITH DISSECTION OF THE COLON AND ANTIMESENTERIC SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAD A COMPLICATED POST-OP COURSE WITH MULTIPLE INFECTIONS AND MULTISYSTEM ORGAN FAILURE, RENAL FAILURE, AND DIALYSIS. THE PATIENT HAD A 94 DAY HOSPITAL STAY. ON (B)(6) 2010, A CT-SCAN OF THE PATIENT'S ABDOMEN AND PELVIS WITHOUT CONTRAST SHOWED 3 SEPARATE LOCULATIONS OF FLUID IN THE ABDOMEN AND PARACOLIC GUTTER. ON (B)(6) 2010, A LEFT ABDOMINAL DRAIN WAS PLACED AND RIGHT PARACENTESIS WAS PERFORMED. ON (B)(6) 2010, A FIBEROPTIC BRONCHOSCOPY WAS PERFORMED DUE TO DENSE BILATERAL UPPER LOBE PNEUMONIA AND RESPIRATORY FAILURE. ON (B)(6) 2012, CT-GUIDED ASPIRATION WAS PERFORMED. ON (B)(6) 2010, THE LEFT UPPER QUADRANT DRAINAGE CATHETER WAS EXCHANGED. ON (B)(6) 2010, INSERTION OF A LEFT INTERNAL JUGULAR VEIN TEMPORARY DIALYSIS CATHETER WAS PERFORMED DUE TO ACUTE ON CHRONIC RENAL FAILURE. ON (B)(6) 2010, A DRAINAGE CATHETER WAS PLACED ON LEFT ABDOMEN FOR AN ABDOMINAL ABSCESS. ON (B)(6) 2010, THE LEFT PERITONEAL WALL ABSCESS HAD COMPLETELY RESOLVED PER A CT-SCAN, WITH A SMALL AMOUNT OF FLUID IN THE ABDOMEN. THE SURGEON NOTED THAT THE FLUID COLLECTION WAS PROBABLY ASCITES AND AN UNCHANGED FLUID COLLECTION IN THE LEFT LOWER QUADRANT (LLQ). ON (B)(6) 2010, INSERTION OF G2 IVC FILTER WAS PERFORMED DUE TO BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVTS) AND PULMONARY EMBOLI (PE) AND AN OCCLUDED RIGHT INTERNAL JUGULAR VEIN. ON (B)(6) 2010, A CT-SCAN SHOWED THE STABLE LLQ FLUID COLLECTION WITH PERSISTENTLY DISTENDED LOOPS OF SMALL BOWEL. ON (B)(6) 2010, DUE TO END-STAGE RENAL DISEASE, A RIGHT INTERNAL JUGULAR VEIN TUNNELED DIALYSIS CATHETER WAS PLACED. THE PATIENT WAS DISCHARGED TO A NURSING HOME ON (B)(6) 2010. THE DISCHARGE DIAGNOSES WERE EXTENSIVE BUT INCLUDED: BENIGN NEOPLASM OF COLON, PULMONARY INSUFFICIENCY FOLLOWING TRAUMA OR SURGERY, SEVERE PERITONEAL ABSCESS, TOXIC ENCEPHALOPATHY, SEPTICEMIA, IATROGENIC PULMONARY EMBOLISM AND INFARCTION WITH PULMONARY COLLAPSE, ACUTE KIDNEY FAILURE WITH END-STAGE RENAL DISEASE, ASPIRATION PNEUMONITIS AND PNEUMONIA DUE TO PSEUDOMONAS, ACIDOSIS, POST-OP INFECTION WITH PERSISTENT MICROORGANISMS, PARALYTIC ILEUS, ACUTE VENOUS EMBOLISM AND DVT OF PROXIMAL LOWER EXTREMITY, ACUTE EMBOLISM AND THROMBOSIS OF THE INTERNAL JUGULAR (IJ) VEINS, HYPEROSMOLALITY AND/OR HYPERNATREMIA, PROTEIN-CALORIE MALNUTRITION, CANDIDIASIS, HYPERLIPIDEMIA, ALZHEIMER'S DISEASE WITH DEMENTIA AND MYOCLONUS, CONGESTIVE HEART FAILURE (CHF), AND DIABETES MELLITUS (DM) II. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, HIS MENTAL STATUS DETERIORATED OVER SEVERAL DAYS AT THE NURSING HOME. THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL ON (B)(6) 2010 WITH AN ALTERED MENTAL STATUS. IMAGING STUDIES DURING THIS ADMISSION SHOWED SEVERE FECAL IMPACTION IN THE RECTUM. GASTROENTEROLOGY OPTED TO TREAT THE PATIENT CONSERVATIVELY BUT SUSPECTED STRICTURE AT THE ANASTOMOSIS. THE PATIENT PASSED AWAY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719189 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L| R