{ "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": "", "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": "2955842-2009-00310", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20090918", "manufacturer_address_2": "", "pma_pmn_number": "K070684", "date_of_event": "20090731", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NOT APPLICABLE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20090928", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20090918", "brand_name": "DA VINCI 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": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS1200 A4.3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20090918", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM", " ACCESSORIES", " INSTRUMENTS" ], "sequence_number_outcome": [ "Death" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Unspecified Infection", "Peritonitis" ] } ], "distributor_city": "", "date_report": "20090825", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1482258", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20090825", "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": "1234063", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 2 DAYS POST A DA VINCI SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE PT DEVELOPED A PERITONITIS INFECTION AND EXPIRED." }, { "mdr_text_key": "8366503", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE: THE PROCEDURE WENT WELL; HOWEVER, THE PT HAD SIGNIFICANT OMENTUM ADHESIONS THAT WERE DIFFICULT TO REMOVE. THE FOLLOWING MORNING, A POST OP EXAMINATION OF THE PT FOUND THAT THE PT WAS DOING WELL; HOWEVER, LATER THAT EVENING, IT WAS NOTED THAT THE PT'S BLOOD PRESSURE DROPPED. THE 2ND DAY POST OP, THE PT'S CONDITION BECAME WORSE AND THE PT EXPIRED LATER THAT EVENING. THERE WAS NO INJURY TO THE PT'S BOWEL OR BLADDER, AND THERE WAS NO VAGINAL SEPARATION OBSERVED. THE PT'S DEVELOPMENT OF PERITONITIS WAS NOT RELATED TO THE ROBOTIC PROCEDURE. NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM WAS ALLEGED BY THE HOSPITAL, AND THE INFORMATION PROVIDED BY THE SITE SUGGESTS THE PT'S PREEXISTING MEDICAL CONDITION (S) CONTRIBUTED TO THIS EVENT. AS OF SEPTEMBER 17, 2009 NO ADVERSE EVENTS OR SYSTEM MALFUNCTIONS HAVE BEEN EXPERIENCED WITH SITE'S DA VINCI SURGICAL SYSTEM." } ], "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": "" } ] }