{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2014-05342", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140904", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140905", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "542216", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140904", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20140904", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Abdominal Pain", "Adhesion(s)", "Atrial Fibrillation", "Bradycardia", "Fistula", "Pleural Effusion", "Renal Failure", "Sepsis", "Urinary Tract Infection", "Peritonitis", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20140805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4061470", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140805", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "4731033", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT AN ATTEMPTED DA VINCI-ASSISTED ROBOTIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND ABDOMINAL COMPLETION OF HYSTERECTOMY FOR ATYPICAL ENDOMETRIAL HYPERPLASIA ON (B)(6) 2010. THE PATIENT ALSO UNDERWENT SEROMUSCULAR REPAIR OF THE BLADDER AND SEROMUSCULAR REPAIR OF THE SIGMOID COLON. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, OTHER MEDICAL RECORDS, AND A DEATH CERTIFICATE. ACCORDING TO THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY. PERTINENT FINDINGS INCLUDED: THE PATIENT WAS NOTED TO HAVE DENSE ADHESIONS OF THE BLADDER TO THE ANTERIOR UTERUS AND ANTERIOR CERVIX. THE OPERATIVE REPORT ALSO STATES, THE PATIENT HAD THE PROCEDURE INITIALLY STARTED ROBOTICALLY, DESPITE MULTIPLE ATTEMPTS TO TRY AND SWEEP THE BOWEL OUT OF THE PELVIS, IT WAS DIFFICULT KEEPING THE SIGMOID COLON AND TO A LESSER DEGREE THE CECUM AND SMALL BOWEL AWAY FROM THE SURGICAL FIELD. DURING MOBILIZATION AND DISSECTION OF THE BLADDER, THE SURGEON NOTED, I WAS USING THE THIRD ARM OF THE ROBOT TO KEEP TRACTION UP ON THE BLADDER TO TRY AND HELP FACILITATE DISSECTING A PLANE BETWEEN THE BLADDER AND THE CERVIX. ULTIMATELY, AS I CONTINUED TO WORK, I BEGAN NOTING AN AREA OF THINNING IN THE BLADDER WALL TO DO REPETITIVE TRACTION ON THE BLADDER GIVEN THAT THE BLADDER WAS SO DENSELY ADHERENT TO THE CERVIX. WHEN I NOTED THAT THE AREA WAS BECOMING THIN, I GREW CONCERNED THAT IF I CONTINUED ROBOTICALLY, I WOULD END UP HAVING A FULL-THICKNESS BLADDER INJURY. AT THIS POINT, WE CONVERTED THE CASE TO AN OPEN CASE. AFTER COMPLETION OF THE HYSTERECTOMY VIA OPEN SURGERY, THE BOWEL WAS EXAMINED AND A SUPERFICIAL 0.5 CM SEROMUSCULAR DEFECT WAS NOTED AND REPAIRED. A CYSTOSCOPY WAS PERFORMED. THE SURGEON INDICATED, THE MUCOSA WAS INTACT THROUGHOUT, BUT I DID NOTE THAT THERE WAS A SEROMUSCULAR DEFECT AS EXPECTED NOTED AT THE TIME OF HER ROBOTIC SURGERY. THIS DEFECT WAS CLOSED... CYSTOSCOPY WAS THEN REPEATED AND NO SUTURE WAS NOTED WITHIN THE BLADDER AND BOTH URETERS READILY SPILLED INDIGO CARMINE DYE. THERE WAS ALSO NO EVIDENCE OF ANY INJURIES AGAIN NOTED IN THE BLADDER. THE BOWEL WAS AGAIN CHECKED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2010. AFTER THE SURGERY, THE PATIENT PRESENTED WITH MULTIPLE HOSPITALIZATIONS FOR BOWEL INJURY AND SEPSIS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011 AND DIAGNOSED WITH A BOWEL PERFORATION WITH SEPSIS, AND SUBSEQUENT ACUTE RENAL FAILURE AND THROMBOCYTOPENIA. ON (B)(6) 2011, SHE UNDERWENT A COLOSTOMY REVERSAL PROCEDURE AND MIDLINE SCAR REVISION FOR ABDOMINAL PAIN, AND A PARASTOMAL HERNIA STATUS POST HARTMANN'S PROCEDURE. ON (B)(6) 2011, SHE UNDERWENT REPAIR OF LEFT COLONIC ANASTOMOSIS BREAKDOWN. THE OPERATIVE REPORT STATES, THE ANASTOMOSIS HAD BEEN A PREVIOUSLY AND SEWN ANASTOMOSIS AND DID NOT APPEAR THAT THESE STITCHES HAD HELD VERY WELL, MOST LIKELY DUE TO POOR TISSUES ON THE PATIENT'S PART. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. SHE RECEIVED TREATMENT FOR AN ENTEROCUTANEOUS FISTULA, ATRIAL FIBRILLATION, BILATERAL PLEURAL EFFUSIONS, AND SEPSIS. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY WITH A PLAN TO RETURN FOR REPAIR OF THE ENTEROCUTANEOUS FISTULA. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011 TO (B)(6) 2012 AND DIAGNOSED WITH AN ENTEROCUTANEOUS FISTULA, URINARY TRACT INFECTION, BACTEREMIA, AND WOUND CARE ISSUES. SHE WAS TRANSFERRED TO ANOTHER FACILITY ON (B)(6) 2012 AND HOSPITALIZED UNTIL (B)(6) 2012 WITH A DIAGNOSIS OF MULTIPLE ENTEROCUTANEOUS FISTULAS, A HISTORY OF DIVERTING COLECTOMY WITH DIVERTING COLOSTOMY, AND A HISTORY OF LAPAROSCOPIC CONVERTED TO OPEN HYSTERECTOMY WITH IATROGENIC BOWEL AND BLADDER INJURY. THE PATIENT WAS HOSPITALIZED IN (B)(6) 2012 AND TREATED FOR UROSEPSIS AND POSSIBLE OSTEOMYELITIS. A RIGHT UPPER QUADRANT SCAN SHOWED MARKED ABNORMALITIES OF THE GALLBLADDER AND SHE UNDERWENT A CHOLECYSTOSTOMY WITH DRAIN PLACEMENT. THE PATIENT WAS ALSO TREATED FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 AND DIAGNOSED WITH AN ENTEROCUTANEOUS FISTULA. SHE WAS TREATED FOR A BILIARY LEAK RESULTING IN PERITONITIS, SEPSIS, AND BRADYCARDIA. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. THE PATIENT PASSED AWAY ON (B)(6) 2013. ACCORDING TO THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS: A) SMALL BOWEL OBSTRUCTION B) SEPSIS C) ABDOMINAL WALL FISTULA." }, { "mdr_text_key": "12332672", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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 REPORTED OPERATIVE COMPLICATIONS. THIS COMPLAINT WAS INITIALLY REPORTED TO THE FDA VIA AN ALTERNATE SUMMARY REPORT SUBMITTED ON 02/27/2014 AS PART OF EXEMPTION (B)(4). REFER TO MDR REPORT 2955842-2014-01197. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: TWO YEARS AND SEVEN MONTHS AFTER HER ATTEMPTED DA VINCI-ASSISTED SURGERY THE PATIENT DIED ON (B)(6) 2013 FROM A SMALL BOWEL OBSTRUCTION, SEPSIS, AND AN ABDOMINAL WALL FISTULA. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS ARE UNKNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }