{ "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": "2955842-2014-01376", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140307", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100831", "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": "20140307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "139667", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140307", "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": [ "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": "20250808", "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": "20140307", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Urinary Retention" ] } ], "distributor_city": "", "date_report": "20131111", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3666918", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131111", "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": "11691610", "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 COMPLICATION(S) EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THE DATE OF THE PATIENT'S DEMISE IS UNKNOWN. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL DOCUMENT PROVIDED CLAIMS THAT THE PATIENT EXPERIENCED URINE BACKING UP IN HIS SYSTEM AND SUBSEQUENTLY PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "4342223", "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 PROSTATECTOMY FOR BENIGN PROSTATIC HYPERPLASIA ON AN UNSPECIFIED DATE IN (B)(6) 2010. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT HAD SURGERY IN (B)(6) OF 2010. AFTER HE HAD SURGERY, HE HAD TO BE RUSHED BACK TO THE HOSPITAL BECAUSE URINE BACKED UP IN HIS SYSTEM. HOWEVER, ON THE WAY TO THE HOSPITAL, HE PASSED AWAY IN THE CAR. ISI WAS PROVIDED WITH THE OPERATIVE REPORT WITH A PROCEDURE DATE OF (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PATIENT WAS FOUND TO HAVE A PROSTATE EXCEEDING 100 ML IN SIZE. THE ESTIMATED BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 250 ML. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS AWOKEN AT THE CONCLUSION OF THE SURGICAL PROCEDURE, EXTUBATED IN THE OPERATING ROOM AND TRANSPORTED TO RECOVERY IN EXCELLENT CONDITION, HAVING TOLERATED THE PROCEDURE WELL. POST-OPERATIVELY ON (B)(6) 2010, A VQ SCAN (VENTILATION-PERFUSION SCAN) WAS OBTAINED AFTER CONSULTATION WITH A PULMONOLOGIST. THE VQ SCAN WAS POSITIVE, HEPARIN WAS ADMINISTERED, AND THE PATIENT WAS PLACED ON TELEMETRY. A POSITIVE VQ SCAN SIGNIFIES A HIGH PROBABILITY OF A PULMONARY EMBOLISM. THE FOLLOWING MORNING A DUPLEX OF THE LOWER EXTREMITIES WAS ORDERED AND NO DEEP VEIN THROMBOSIS (DVT) WAS FOUND. THE PATIENT WAS TAKEN TO THE OPERATING ROOM BY A VASCULAR SURGEON FOR PLACEMENT OF AN INFERIOR VENA CAVAL FILTER SINCE HE WAS CONTRAINDICATED FOR HEPARINIZATION AT THAT POINT. A CYSTOGRAM ON (B)(6) 2010 SHOWED NO LEAKAGES. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED HOME AFTER DEMONSTRATING THE ABILITY TO VOID. ON (B)(6) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND CONFIRMED THAT THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER DID NOT HAVE ANY INFORMATION TO PROVIDE REGARDING THE PATIENT AFTER HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. SHE DID NOT HAVE ANY INFORMATION REGARDING THE PATIENT'S REPORTED POST-OPERATIVE COMPLICATIONS OR DEMISE." } ], "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": "" } ] }