{ "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": "2955842-2014-05629", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141107", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130620", "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": "20141110", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "719507", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141107", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20141107", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Death", "Edema", "Fatigue", "Low Blood Pressure/ Hypotension", "Hypoxia", "Renal Failure", "Tachycardia", "Fasciitis", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20141010", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4238075", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141010", "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": "4976280", "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 HYSTERECTOMY PROCEDURE WITH BILATERAL URETEROLYSIS AND LYSIS OF SEVERE ADHESIONS FOR HIGH RISK UTERINE CANCER (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT SUSTAINED A SMALL BOWEL PERFORATION, DEVELOPED NECROTIZING FASCIITIS, AND SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. POST-OPERATIVELY, THE PATIENT'S ABDOMEN WAS FOUND TO BE SOFT AND BOWEL SOUNDS WERE PRESENT. NO DISTENTION WAS OBSERVED. THE PATIENT WAS ABLE TO AMBULATE, TOLERATE A REGULAR DIET, AND VOID. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED. ON (B)(6) 2013, THE PATIENT WAS ADMITTED WITH WORSENING ABDOMINAL PAIN, SOMNOLENCE, AND ANOREXIA. THE PATIENT WAS FOUND TO BE TACHYCARDIC, HYPOTENSIVE, AND HYPOXIC. THE PATIENT'S WHITE BLOOD CELL COUNT WAS 5.9 WITH 92% BANDS. A CT SCAN SHOWED FREE INTRAPERITONEAL AIR AND FREE AIR ALONG THE ENTIRE LEFT SIDE OF THE ABDOMEN. THE PATIENT WAS TAKEN URGENTLY TO THE OPERATING ROOM AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED. ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL WERE OBSERVED. IN ADDITION, A SMALL BOWEL PERFORATION AND NECROTIZING FASCIITIS ON THE LEFT LOWER ABDOMEN AND FLANK WERE FOUND. THE SMALL BOWEL PERFORATION WAS REPAIRED WITH 2-LAYER SUTURING. EXTENSIVE SHARP DEBRIDEMENT OF A 30 CM AREA OF NECROTIZING FASCIITIS WAS PERFORMED. IN ADDITION, ABDOMINAL IRRIGATION WITH SALINE AND ANTIBIOTIC SOLUTION WAS PERFORMED. THE PATIENT'S ABDOMEN WAS LEFT OPENED DUE TO MARKED EDEMA OF THE SMALL BOWEL. A BOGOTA BAG AND A JP DRAIN WERE PLACED. ALSO, A TRIPLE LUMEN CATHETER AND ARTERIAL LINE WERE PLACED. POST-OPERATIVELY, THE PATIENT REMAINED IN THE ICU ON A VENTILATOR AND PRESSORS. A BLOOD CULTURE WAS OBTAINED AND GREW ENTEROBACTER GROUP B STREP. THE PATIENT WAS THEN PLACED ON MAXIMUM SUPPORT. OVER THE NEXT 24 HOURS, THE PATIENT EXPERIENCED PROGRESSIVE DETERIORATION AND RENAL FAILURE. THE PATIENT REQUIRED INCREASED PRESSORS AND VENTILATOR MANAGEMENT. ON (B)(6) 2013, THE PATIENT'S FAMILY DECIDED ON DNR (DO NOT RESUSCITATE). ON (B)(6) 2013, THE PATIENT'S BLOOD PRESSURE AND PULSE WAS LOST. THE PATIENT WAS PRONOUNCED DEAD AT 1:01 AM." }, { "mdr_text_key": "12462913", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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) 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 SI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND DEATH 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": "" } ] }