{ "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": "2955842-2012-00226", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120523", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20120430", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120524", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120523", "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": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20120523", "sequence_number_treatment": [ "DA VINCI S INSTRUMENTS & ACCESSORIES, ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "78", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20120501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2585957", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120501", "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": "17476968", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, ISI'S CLINICAL SALES REPRESENTATIVE (INITIAL REPORT) INDICATED THAT HE SPOKE TO DR. (B)(6), THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE AND DR. (B)(6) REPORTED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. DR. HARDEN REPORTED THAT THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AFTER APPROXIMATELY 3 HOURS AND INTRA-OPERATIVELY THE PATIENT TOLERATED THE PLANNED SURGICAL PROCEDURE WELL. DR. HARDEN INDICATED THAT APPROXIMATELY 3 TO 4 HOURS POST- OP THE PATIENT'S FOLEY CATHETER WAS REMOVED, THE PATIENT WAS ABLE TO WALK AROUND AND APPEARED TO BE DOING WELL AND THE NEXT DAY AT APPROXIMATELY 6:30 AM, SHE RECEIVED A CALL ADVISING THAT THE PATIENT EXPIRED. PER DR. (B)(6), AN AUTOPSY WAS PERFORMED AND THERE WAS NO EVIDENCE OF HEMORRHAGING OR PULMONARY EMBOLISM AND IT IS BELIEVED THAT THE PATIENT'S DEMISE WAS A RESULT OF CONSUMING TOO MANY NARCOTICS. ON (B)(6) 2012, ISI CONTACTED DR. (B)(6) AND SHE INDICATED THAT THE PATIENT UNDERWENT THE DA VINCI S HYSTERECTOMY PROCEDURE DUE TO DYSFUNCTIONAL BLEEDING AND THAT THE PATIENT WAS TAKING ANTI-DEPRESSANTS DUE TO DEPRESSION AND THAT THE PATIENT'S SISTER CONTACTED HER AFTER THE PATIENT EXPIRED AND ADVISED DR. (B)(6) THAT THE PATIENT CONSUMED ALCOHOL WHILE TAKING ANTI-DEPRESSANT MEDICATIONS. A TOXICOLOGY REPORT IS CURRENTLY PENDING. DR. (B)(6) INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT TOLERATED THE PLANNED SURGICAL PROCEDURE WELL. SHE IS UNABLE TO PROVIDE THE PATIENT'S RECORDS; HOWEVER, IT IS HER BELIEF THAT THE PATIENT'S DEMISE IS UNRELATED TO THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. ON (B)(6) 2012, ISI CONTACTED (B)(6) IN THE PATIENT SAFETY DEPARTMENT AT (B)(6) AND SHE INDICATED THAT SHE IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION CONCERNING THE PATIENT DUE TO HIPPA REGULATIONS." }, { "mdr_text_key": "17197768", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 1 DAY AFTER A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED." } ], "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": "" } ] }