{ "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": "2955842-2014-00358", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140117", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101208", "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": "20140121", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "44353", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140117", "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": "20250805", "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": "20140117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Aspiration/Inhalation", "Cardiopulmonary Arrest", "Death", "Edema", "Fistula", "Pleural Effusion", "Renal Failure", "Abnormal Vaginal Discharge", "Stenosis", "Obstruction/Occlusion", "Cognitive Changes", "Cancer" ] } ], "distributor_city": "", "date_report": "20140102", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3582679", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140102", "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": "4034275", "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 THAT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2010 AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT FOR A MODIFIED RADICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL LYMPHADENECTOMY, AND DEBULKING OF LEFT OBTURATOR ADENOPATHY WAS PERFORMED FOR CLINICAL STAGE IA2 ADENOCARCINOMA OF THE CERVIX. ADDITIONAL INFORMATION PROVIDED INCLUDES: DISCHARGE SUMMARIES, SUBSEQUENT OPERATIVE REPORTS, AND A DEATH CERTIFICATE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT WAS DISMISSED TO THE RECOVERY ROOM AND THEN DISCHARGED IN STABLE CONDITION ON (B)(6) 2010, THE SAME DAY. THE DISCHARGE SUMMARY NOTED THAT THE PATIENT HAD TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED IN STABLE CONDITION. ACCORDING TO THE PATIENT'S MEDICAL RECORDS DATED (B)(6) 2010 THROUGH (B)(6) 2011, THE PATIENT EXPERIENCED COMPLICATIONS THAT INCLUDED VAGINAL LEAKING, ABDOMINAL PAIN, ACUTE RENAL FAILURE, PSYCHOTIC BEHAVIOR (DELUSIONS, HALLUCINATIONS, AND AGGRESSIVE BEHAVIOR), AND POSSIBLE BOWEL OBSTRUCTION. IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH A URETERAL VAGINAL FISTULA AND THE PATIENT UNDERWENT A CYSTOSCOPY BILATERAL RETROGRADE PYELOGRAM AND RIGHT URETERAL STENT PLACEMENT FOR RIGHT URETEROVAGINAL FISTULA. IN (B)(6) 2011, THE PATIENT PRESENTED WITH INCREASED ABDOMINAL PAIN AND HAD A BILATERAL ANTEGRADE NEPHROSTOGRAM AND POSSIBLE BILATERAL PLACEMENT OF NEPHROSTOMY TUBES DUE TO LEAKAGE FROM VAGINA AND POST-OP VAGINAL FISTULA. IN (B)(6) 2011, THE PATIENT WAS ADMITTED FOR ACUTE RENAL FAILURE AND CHRONIC PAIN. THE PATIENT RECEIVED BILATERAL NEPHROSTOMY TUBES BUT PROCEEDED WITH WHAT WAS NOTED WITH EXTREMELY PSYCHOTIC BEHAVIOR WITH DELUSIONS, HALLUCINATIONS AND AGGRESSIVE BEHAVIOR. CT'S AND OF THE PATIENTS HEAD AND EEG STATS WERE FOUND NORMAL. THE PATIENT HAD A REMOVAL OF THE RIGHT URETERAL STENT; AT THAT TIME IT WAS NOTED THAT THE RIGHT NEPHROSTOMY TUBE WAS NOT CORRECTLY PLACED IN THE COLLECTING SYSTEM. THE PATIENT UNDERWENT A SECOND PSYCHOTIC EPISODE THAT DELAYED THE RE-ADJUSTMENT. ON (B)(6) , THE PATIENT PRESENTED WITH A POSSIBLE BOWEL OBSTRUCTION AND PAIN. THE PATIENT WAS DIAGNOSED WITH BILATERAL URETERAL STENOSIS FROM L3 DOWN TO THE URETERAL ORIFICE. PATIENT UNDERWENT A CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, RIGHT SEMI-RIGID URETEROSCOPY AND RIGHT ANTEGRADE NEPHROSTOGRAM. SHE HAD A MASSIVE BULLOUS EDEMA OF TRIGONE WITH AN INCOMPETENT URETHRA. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH BILATERAL DISTAL URETERAL STENOSIS AND A RIGHT URETERAL VAGINAL FISTULA. SHE UNDERWENT A CYSTOSCOPY, RIGHT RETROGRADE RIGID SEMI RIGID UTEROSCOPY, RIGHT PERCUTANEOUS ANTEGRADE NEPHROSTOGRAM, RIGHT ANTEGRADE NEPHROURETREROSCOPY, RIGHT PERCUTANEOUS TRACT DILATION AND RIGHT ANTEGRADE URETERAL STENT PLACEMENT. SHE WAS FOUND TO HAVE A DISTAL URETERAL VAGINAL FISTULA, DISTAL URETERAL STENOSIS, AND MASSES BULLOUS EDEMA OF THE BLADDER. ON (B)(6) 2011 THE PATIENT UNDERWENT THORACENTESIS FOR ASPIRATION DUE TO LEFT-SIDED MODERATE PLEURAL EFFUSION. SHE WAS DISCHARGED ON (B)(6) 2011. ACCORDING TO AN OPERATIVE REPORTED WITH A DATE OF (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND TREATED FOR BILATERAL URETERAL STENOSIS FROM L3 DOWN TO THE URETERAL ORIFICE , BILATERAL DISTAL URETERAL STENOSIS AND A RIGHT URETERAL VAGINAL FISTULA, AND RECURRENT MALIGNANT PLEURAL EFFUSION IN THE LEFT HEMITHORAX. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ACCORDING TO HER DEATH CERTIFICATE, THE CAUSE OF DEATH WAS ACUTE CARDIOPULMONARY ARREST AND METASTATIC CANCER OF THE UTERINE CERVIX. NO FURTHER INFORMATION IS AVAILABLE." }, { "mdr_text_key": "11442683", "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 OF THE POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. 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: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 3.5 MONTHS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." } ], "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": "" } ] }