{ "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": "2955842-2016-00195", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20160324", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160129", "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 REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160324", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "178435", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160324", "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, A60P9B", "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": [ "Device Inoperable" ], "reporter_state_code": "NM", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20160324", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Death" ] } ], "distributor_city": "", "date_report": "20160223", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5524386", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160223", "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": "42792515", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IN RELATION TO THE REPORTED EVENT, THE SITE'S RISK MANAGEMENT DIRECTOR INDICATED ON 03/30/2016 AND 04/12/2016 THAT THERE WERE NO ISSUES WITH THE DA VINCI SURGICAL SYSTEM. THE RISK MANAGEMENT DIRECTOR DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT SUCH AS: THE REASON WHY THE CASE WAS CONVERTED TO OPEN SURGERY, WHAT POST-OPERATIVE COMPLICATIONS THE PATIENT EXPERIENCED, THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS, WHAT DATE THE PATIENT PASSED AWAY, AND THE CAUSE OF THE PATIENT'S DEATH. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY FOR AN UNKNOWN REASON. THE PATIENT REPORTEDLY DEVELOPED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND PASSED AWAY ON AN UNSPECIFIED DATE. THE CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH ARE UNKNOWN." }, { "mdr_text_key": "41118888", "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 ALLEGED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. IN ADDITION, THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE TWO INSTRUMENTS USED DURING THE SURGICAL PROCEDURE, A PROGRASP FORCEPS INSTRUMENT AND A MONOPOLAR CURVED SCISSORS INSTRUMENT, HAVE BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES WITH NO REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AS A RESULT OF UNSPECIFIED INTRA-OPERATIVE COMPLICATIONS, THE DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE WAS CONVERTED TO OPEN SURGERY. AFTER THE OPEN SURGERY WAS COMPLETED, THE PATIENT EXPERIENCED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "41118889", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED INTRA-OPERATIVE COMPLICATIONS AND THE CASE WAS CONVERTED TO OPEN SURGERY. POST-OPERATIVELY, THE PATIENT EXPERIENCED COMPLICATIONS AND THE PATIENT SUBSEQUENTLY PASSED AWAY ON AN UNKNOWN DATE. ON 03/18/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. TO HER KNOWLEDGE, THE PATIENT SUSTAINED AN UNSPECIFIED TYPE OF BOWEL INJURY. SHE DID NOT KNOW THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS OR DEATH." } ], "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": "04/15/2016" } ] }