{ "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": "I", "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": "Injury", "report_number": "2955842-2017-00806", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20171129", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20160226", "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": [ "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171129", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "848719", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171129", "brand_name": "DA VINCI XI 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": "IS4000 A70P6B", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20171129", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cancer", "Cancer" ] } ], "distributor_city": "", "date_report": "20171103", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7069261", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171103", "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": "93292480", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SURGEON'S PROCEDURE HISTORY AND THERE IS NO INDICATION THAT THE SURGEON PERFORMED A DA VINCI-ASSISTED SURGICAL PROCEDURE ON (B)(6) 2016 AS PROVIDED BY THE PATIENT. THE SURGEON PERFORMED TWO DA VINCI-ASSISTED HYSTERECTOMY PROCEDURES ON (B)(6) 2016. ACCORDING TO THE AVAILABLE SYSTEM LOGS, NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE TWO SURGICAL PROCEDURES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT CLAIMED THAT A BIOPSY OF A PEA-SIZED NODULE LOCATED AT A ROBOTIC PORT SITE SHOWED METASTATIC ENDOMETRIOID ADENOCARCINOMA. HOWEVER, THE ROOT CAUSE OF THE PEA-SIZED NODULE THAT SHOWED METASTATIC ENDOMETRIOID ADENOCARCINOMA IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED." }, { "mdr_text_key": "93292481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 11/03/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5072789 WITH THE FOLLOWING EVENT DESCRIPTION: I HAD A TOTAL HYSTERECTOMY ON (B)(6) FOR ENDOMETRIAL CANCER. MY SURGEON USED THE DAVINCI ROBOTIC DEVICE TO PERFORM THE SURGERY. IN (B)(6), I WAS DIAGNOSED WITH RECURRENT CANCER AND A PEA-SIZED NODULE AT ONE OF THE DAVINCI PORT SITES WAS CONFIRMED POSITIVE FOR ENDOMETRIAL CANCER METASTASIS. ON 11/08/2017, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DIRECTLY FROM THE PATIENT: THE PATIENT UNDERWENT A DA VINCI LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, WASHINGS, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION SURGERY ON (B)(6) 2016. SHE WAS DIAGNOSED WITH ENDOMETRIAL ENDOMETRIOID STAGE 1A, GRADE 2, WITH 18 NEGATIVE LYMPH NODES. ON (B)(6) 2016, THE PATIENT HAD A VAGINAL VAULT LESION BIOPSY THAT WAS CONFIRMED POSITIVE FOR METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON (B)(6) 2016, THE PATIENT HAD A BIOPSY OF A PEA-SIZED NODULE, LOCATED AT THE RIGHT LOWER QUADRANT ROBOTIC PORT SITE. THE PATIENT INDICATED THAT THE BIOPSY OF THE PEA-SIZED NODULE ALSO SHOWED INVOLVED BY METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON 11/28/2017, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ACCORDING TO THE RISK MANAGER, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR REPORTS OF ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM. THE RISK MANAGER ALSO REVIEWED ADDITIONAL MEDICAL RECORDS FROM THE PATIENT AND CONFIRMED THAT BIOPSIES WERE PERFORMED ON (B)(6) 2016. AS OF THE DATE OF THIS REPORT, THERE ARE NO ALLEGATIONS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION(S)." } ], "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": "" } ] }