{ "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": "2955842-2015-00192", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150130", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131008", "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": "20150130", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "72377", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150130", "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", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20150130", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "77 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Bradycardia", "Cardiopulmonary Arrest", "Death", "Dyspnea", "Edema", "Fatigue", "Low Blood Pressure/ Hypotension", "Unspecified Infection", "Renal Failure", "Sepsis", "Septic Shock", "Vomiting", "Loss of consciousness", "Respiratory Failure", "Confusion/ Disorientation", "Constipation" ] } ], "distributor_city": "", "date_report": "20150102", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4470004", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150102", "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": "12797244", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. 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." }, { "mdr_text_key": "5402041", "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 A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR POORLY DIFFERENTIATED ENDOMETRIAL CANCER ON (B)(6) 2013. THE PATIENT ALSO UNDERWENT LYMPH NODE MAPPING, BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY, OMENTAL BIOPSY, AND CYSTOSCOPY. 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. ACCORDING TO THE OPERATIVE REPORT, NO COMPLICATIONS WERE REPORTED. POST-OPERATIVELY, THE PATIENT'S MENTAL STATUS CONSISTED OF CONFUSION. HOWEVER, AT THE TIME OF DISCHARGE ON (B)(6) 2013, THE PATIENT WAS REPORTEDLY FINE. THE PATIENT HAD POSITIVE BOWEL SOUNDS. ON (B)(6) 2013, THE PATIENT HAD COMPLAINTS OF SEVERE LOWER ABDOMINAL PAIN AND COULD NOT GET OUT OF BED. PAIN MEDICATIONS WERE NOT HELPING. THE PATIENT WAS ADVISED TO CALL FOR AN AMBULANCE AND REPORT TO A PHYSICIAN AS SOON AS POSSIBLE. ON (B)(6) 2013, THE PATIENT WAS SEEN IN AN ER. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS SINCE PRIOR TO SURGERY. SHE HAD NO FEVER. THE PATIENT VOMITED ONE TIME. A KIDNEY, URETER, BLADDER (KUB) X-RAY SHOWED A MODERATE AMOUNT OF RETAINED FECES IN THE COLON; LIKELY CONSTIPATION. NO EVIDENCE OF AN OBSTRUCTION OR PERFORATION WAS FOUND. THE PATIENT WAS NOT FOUND TO HAVE A SURGICAL ABDOMEN. AN ENEMA WAS GIVEN WITH RESULTS. THE PATIENT HAD RELIEF OF ABDOMINAL PAIN AND WAS STABLE. THE PATIENT WAS ADVISED TO HAVE A STRICT BOWEL REGIMEN WITH SENOKOT AND INCREASED ORAL FLUIDS. SHE WAS INSTRUCTED TO RETURN FOR WORSENING SYMPTOMS. A FOLLOW-UP WAS PLANNED IN 2 WEEKS. THE PATIENT WAS DISCHARGED. ON (B)(6) 2013, THE PATIENT PRESENTED TO A MEDICAL CENTER VIA AMBULANCE. THE PATIENT WAS FOUND AT HOME WITH SHORTNESS OF BREATH (SOB), SOMNOLENCE, AND HYPOTENSION. IN THE ER, THE PATIENT RESPONDED TO VERBAL QUESTIONING AND ANSWERED TO NAME. SHE WAS ADMITTED WITH RESPIRATORY FAILURE, SEPSIS, SEPTIC SHOCK, CARDIOPULMONARY ARREST, HYPOTENSION, RENAL FAILURE, AND LACTIC ACIDOSIS. A VENOUS DOPPLER WAS NEGATIVE. A NG TUBE, FOLEY, AND RIGHT FEMORAL VENOUS LINE WERE PLACED. ON (B)(6) 2013, A KUB X-RAY SHOWED A GASSY COLON AND SMALL BOWEL, SUGGESTIVE OF ILEUS. NO FREE AIR WAS IDENTIFIED. THE PATIENT BECAME UNRESPONSIVE, BRADYCARDIC. THE PATIENT EXPERIENCED 3 CARDIOPULMONARY ARRESTS IN THE ER AND WAS RESUSCITATED SUCCESSFULLY. THE PATIENT WAS INTUBATED AND GIVEN MAXIMUM PRESSORS, IV FLUIDS, AND ANTIBIOTICS. THE PATIENT HAD SEVERE NEUTROPENIA, METABOLIC ACIDOSIS WITH SEVERE LACTIC COMPONENT, AND ACUTE RENAL FAILURE. THE PATIENT WAS TRANSFERRED TO ICU. HER CONDITION SOMEWHAT STABILIZED. ON (B)(6) 2013, A CT-SCAN SHOWED EVIDENCE OF DIVERTICULOSIS OF THE SIGMOID COLON WITH NO SIGNS OF DIVERTICULITIS. THE PATIENT HAD SCATTERED SUBCUTANEOUS EDEMA AND SUBCUTANEOUS AIR OR GAS PARTICULARLY IN THE RIGHT CHEST AND ABDOMEN. A LARGE AMOUNT OF FREE AIR IN THE PERITONEAL CAVITY WAS IDENTIFIED. A BOWEL PERFORATION WAS SUSPECTED. THE PATIENT STILL REQUIRED VASOPRESSORS AND WAS MECHANICALLY VENTILATED. UPON DISCUSSION, THE PATIENT'S FAMILY DECIDED FOR COMFORT CARE ONLY MANAGEMENT DUE TO THE PATIENT'S GENERAL CONDITION, SEVERITY OF ILLNESS, AND EXISTING LIVING WILL. BLOOD CULTURES GREW ESCHERICHIA COLI, BACTEROIDES UREOLYTICUS, AND PROPIONIBACTERIUM ACNES. THE PATIENT PASSED AWAY PEACEFULLY ON (B)(6) 2013. THE LAST MEDICAL RECORD REVIEWED WAS FROM (B)(6) 2013. A POSITIVE LYNCH TEST FROM THE DECEDENT'S TUMOR SPECIMEN WAS DISCUSSED. ALSO, A GENETIC COUNSELING EVALUATION OF THE FAMILY WAS DISCUSSED." } ], "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": "" } ] }