{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-13650", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220825", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220719", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220825", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20180928", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2256779", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220825", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380601-33", "catalog_number": "380601", "lot_number": "N/A", "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": "00886874114605", "udi_public": "(01)00886874114605", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/15/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250805", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220825", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "96 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Renal Failure", "Hypovolemia", "Hyponatremia", "Renal Failure", "Hypovolemia", "Hyponatremia" ] } ], "distributor_city": "", "date_report": "20220725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15290632", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220725", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "298564290", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CAN BE ATTRIBUTED TO THE PROCEDURE AND UNDERLYING DISEASE AND IS UNRELATED TO THE STUDY DEVICE, ACCORDING TO THE STUDY INVESTIGATOR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE SYSTEM AND INSTRUMENT LOGS FOR THIS EVENT CANNOT BE REVIEWED AS THE PROCEDURE WAS PERFORMED ON A DA VINCI SP SYSTEM. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED LAR PROCEDURE, THE PATIENT EXPERIENCED ACUTE RENAL FAILURE ON POD #1. THE PATIENT ENCOURAGED TO INCREASE ORAL INTAKE AND WAS TREATED WITH IV FLUIDS. THE POST-OPERATIVE COMPLICATION RESOLVED ON POD #2. THE STUDY INVESTIGATOR ATTRIBUTED POST-OPERATIVE COMPLICATION TO THE PROCEDURE AND UNDERLYING DISEASE. IN ADDITION, THE STUDY INVESTIGATOR INDICATED THAT THE POST-OPERATIVE COMPLICATION WAS UNRELATED TO THE STUDY DEVICE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "298564291", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE PATIENT'S URINE OUTPUT WAS BORDERLINE LOW, SO BASIC LABS WERE ASSESSED. ON POSTOPERATIVE DAY (POD) #1 (B)(6) 2022), THE PATIENT HAD LOW URINE OUTPUT AND WAS ENCOURAGED TO TRY CLEAR FLUIDS. THE PATIENT'S CREATININE LEVELS WERE NOTED TO HAVE RISEN TO 2.32 (FROM 1.02), SODIUM WAS 127 AND THE HEMOGLOBIN WAS NOTED TO BE LOW AT 8.8. THE PATIENT WAS STARTED ON IV FLUIDS AND CANDESARTAN, CHLORTHALIDONE AND SPIRONOLACTONE WERE HELD AT THIS TIME. THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY DUE TO HYPOVOLEMIA, AND HYPONATREMIA. ON POD #2 (B)(6) 2022), SHE WAS AGAIN ENCOURAGED TO INCREASE ORAL INTAKE. THE CREATININE WAS TRENDING DOWNWARD AT 1.81, SODIUM WAS 129 AND HEMOGLOBIN WAS STABLE AT 8.3. DIARRHEA WAS ALSO NOTED (STARTED ON POD #2). ON POD #3 (B)(6) 2022), THE PATIENT'S URINE OUTPUT WAS NOTED TO BE ADEQUATE. THE PATIENT WAS DISCHARGED THAT SAME DAY WITH A RECOMMENDATION TO FOLLOW UP WITH HER PRIMARY CARE PHYSICIAN IN 1-2 WEEKS ON AN OUT-PATIENT BASIS WITH BMP FOLLOW UP. A PATHOLOGY REPORT ON (B)(6) 2022 DEMONSTRATED INVASIVE MODERATELY DIFFERENTIATED ADENOCARCINOMA ARISING IN A BACKGROUND OF TUBULOVILLOUS ADENOMA. ONE (1/17) LYMPH NODE WAS POSITIVE FOR METASTATIC ADENOCARCINOMA. THE STUDY INVESTIGATOR ASSESSED THE EVENT OF ACUTE RENAL FAILURE WITH ONSET ON (B)(6) 2022 AND RESOLUTION ON (B)(6) 2022 AS AN UNANTICIPATED ADVERSE EVENT (AE) RELATED TO THE PROCEDURE AND THE UNDERLYING DISEASE AND NOT RELATED TO THE DEVICE. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI PROCEDURE. ON BOTH THE 14-DAY FOLLOW UP AND THE 42-DAY FOLLOW UP VISIT, THE PATIENT WAS NOTED TO HAVE NOT EXPERIENCED ANY ADVERSE EVENTS." }, { "mdr_text_key": "340138111", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON (B)(6) 2022, THE SUBJECT UNDERWENT ROBOT-ASSISTED RIGHT COLECTOMY PROCEDURE USING THE DA VINCI SP SURGICAL SYSTEM." }, { "mdr_text_key": "340138112", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/06/2024" } ] }