{ "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": "2955842-2014-05284", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140827", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "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": "20140828", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "519888", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140827", "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": "DA", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "20140827", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20140728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4042636", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140926", "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": "4723629", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. HOWEVER, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE CONVERSION TO OPEN SURGERY WAS UNRELATED TO ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE INITIAL REPORTER WAS INFORMED THAT THE ROBOTIC PART OF THE PROCEDURE HAD ALREADY BEEN COMPLETED BY THE TIME THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY. SHE INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED ALTHOUGH THE PATIENT WAS NOT DOING WELL POST-OPERATIVELY. ON (B)(6) 2014, THE INITIAL REPORTER WAS NOTIFIED BY THE SITE THAT THE PATIENT HAD PASSED AWAY. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON WAS AWARE THAT THE DA VINCI NEPHRECTOMY WAS GOING TO BE DIFFICULT EVEN BEFORE THE PROCEDURE BEGAN. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO THE SIZE AND LOCATION OF THE PATIENT'S TUMOR. THE SURGEON INDICATED THAT THE TUMOR WAS TOO FAR EMBEDDED AND HE DID EVERYTHING HE COULD WITH THE DA VINCI SURGICAL SYSTEM BEFORE DECIDING TO CONVERT TO OPEN SURGERY. THE PATIENT REPORTEDLY PASSED AWAY HOURS AFTER THE SURGICAL PROCEDURE WAS COMPLETED. THE INITIAL REPORTER DID NOT KNOW THE CAUSE AND DATE OF THE PATIENT'S DEATH." }, { "mdr_text_key": "12276548", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT PASSED AWAY AFTER UNDERGOING A DA VINCI NEPHRECTOMY PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY DUE TO A TUMOR SIZE AND LOCATION. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE IS UNKNOWN." }, { "mdr_text_key": "12289793", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (B)(4) CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI NEPHRECTOMY PROCEDURE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD ADVANCED RENAL CARCINOMA THAT HAD SPREAD FROM THE RIGHT KIDNEY TO THE VENA CAVA AND DOWN TO AN ILIAC VESSEL AND THAT THE PATIENT HAD HIGH MORBIDITY CANCER RESULTING IN A VERY COMPLEX CASE. THE SURGEON STATED THAT ALTHOUGH THE SURGERY TOOK APPROXIMATELY 12 HOURS, THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE SURGEON INDICATED THAT THE PATIENT WAS TAKEN TO THE ICU WHERE SHE DEVELOPED VENTILATION ISSUES. ACCORDING TO THE SURGEON, THE PATIENT CODED 3 TIMES AND ULTIMATELY EXPIRED THE NEXT DAY, EARLY IN THE MORNING. THE SURGEON STATED THAT HE HAD SPOKEN TO VARIOUS MEMBERS OF THE SURGERY DEPARTMENT AND THE CONCLUSION WAS MADE THAT THE PATIENT'S DEATH WAS POSSIBLY CAUSED BY A TRANSFUSION RELATED PULMONARY REACTION. NO FURTHER INFORMATION WAS PROVIDED." } ], "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": "10/17/2014" } ] }