{ "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": "2955842-2023-10687", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230215", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230116", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Study", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230215", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201124", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1318384", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230215", "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": "380601-40", "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": "11/28/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "", "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": "20230215", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "83 YR", "patient_sex": "Female", "patient_weight": "63 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Unspecified Gastrointestinal Problem", "Unspecified Gastrointestinal Problem" ] } ], "distributor_city": "", "date_report": "20230120", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16378852", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230120", "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": "309581218", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED AS PART OF A CLINICAL TRIAL THAT 2 DAYS AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME), THE PATIENT EXPERIENCED LIGHTHEADEDNESS WITH NAUSEA AND VOMITING. A NASOGASTRIC WAS PLACED, AND ILEUS WAS SHOWN ON X-RAY. BLOOD WORK SHOWED NO CONCERNS OF BLEEDING OR INFECTION. IV FLUIDS WERE GIVEN TO THE PATIENT. NO MALFUNCTIONS OF SP SYSTEM OR INSTRUMENTS WERE REPORTED, AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE SURGERY. ON POST-OPERATIVE DAY (POD) #5, THE PATIENT WAS REPORTED RESOLVED FROM ILEUS. THE PATIENT WAS DISCHARGED ON POD #6 WITH NORMAL BOWEL FUNCTION AND WAS TOLERATING A GENERAL DIET." }, { "mdr_text_key": "309581219", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE ILEUS CANNOT BE DETERMINED. THERE IS NO CLAIM AGAINST AN ISI PRODUCT AND NO INDICATION OF A PRODUCT ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: TWO DAYS AFTER A DA VINCI-ASSISTED LAR WITH TME, THE PATIENT HAD ILEUS PRIOR TO DISCHARGE AND A NASOGASTRIC WAS PLACED. IV FLUIDS WERE ALSO GIVEN TO THE PATIENT. THE PATIENT WAS DISCHARGED ON POD #6 AFTER APPROPRIATE BOWEL FUNCTION WAS NOTED AND THE PATIENT WAS ABLE TO TOLERATE A GENERAL DIET." }, { "mdr_text_key": "338669928", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PATIENT UNDERWENT A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY AS PART OF A CLINICAL STUDY ON (B)(6) 2023, AND TWO DAYS LATER, THE PATIENT EXPERIENCED LIGHTHEADEDNESS WITH NAUSEA AND VOMITING. CORRECTION TO FIELD B3 (EVENT DATE) TO (B)(6) 2023. THE PROCEDURE NAME IS BEING CORRECTED FROM LOWER ANTERIOR RESECTION TO RIGHT HEMICOLECTOMY." }, { "mdr_text_key": "338669929", "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": "12/13/2023" } ] }