{ "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": "2955842-2023-10477", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230202", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20211022", "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": "20230202", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200123", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "384382", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230202", "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": "", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20230202", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "51 YR", "patient_sex": "Female", "patient_weight": "165 KG", "patient_ethnicity": "Hispanic", "patient_race": "White", "patient_problems": [ "Post Operative Wound Infection", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20230105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16285930", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230105", "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": "308665194", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS NOT PERFORMED FOR THIS PROCEDURE SINCE THE SYSTEM LOGS ARE NOT AVAILABLE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED LAR WITH TME AND LOW ANASTOMOSIS ON (B)(6) 2021, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON POD #13. THE UMBILICAL INCISION HAD ECCHYMOSIS CONSISTENT WITH PRESSURE FROM THE ROBOT AND SOME SEROUS DRAINAGE WAS OBSERVED. THE INCISION WAS OPENED, AND THE SEROSANGUINOUS DRAINAGE WAS EXPELLED. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "308665197", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) AND LOW ANASTOMOSIS ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) #2, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON POD #13. THE UMBILICAL INCISION HAD ECCHYMOSIS CONSISTENT WITH PRESSURE FROM THE ROBOT AND SOME SEROUS DRAINAGE WAS OBSERVED. THE INCISION WAS OPENED, AND THE SEROSANGUINOUS DRAINAGE WAS EXPELLED. THE WOUND WAS THEN PACKED WITH ½-INCH IODOFORM, COVERED WITH 4X4 GAUZE. THE INFECTION WAS RESOLVED BY POD #43." } ], "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": "" } ] }