{ "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": "2955842-2024-10939", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240205", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220510", "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": "20240205", "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": "1558445", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240205", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20240205", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "46 YR", "patient_sex": "Female", "patient_weight": "56 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Seroma", "Seroma" ] } ], "distributor_city": "", "date_report": "20240109", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18640681", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240109", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "334552192", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA VINCI ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) ON 10-MAY-2022 AS PART OF A CLINICAL STUDY. IT WAS NOTED THAT THE PATIENT WAS FOUND WITH SUPERFICIAL FLUID COLLECTION CONSISTENT WITH A SEROMA ON 29-NOV-2022 ON THE MEDIAL OF THE SCAR FROM THE COLOSTOMY TAKEDOWN. THERE WAS NO REPORT OF FEVER, CHILLS OR PURULENT DRAINAGE. DRAINAGE WAS PERFORMED BY THE DERMATOLOGIST, AND WAS DRESSED WITH A BAND-AID. NO ANTIBIOTICS WERE PRESCRIBED BUT TYLENOL WAS RECOMMENDED FOR PAIN CONTROL IF NECESSARY. THE SEROMA WAS REPORTED AS RESOLVED ON 21-DEC-2022. THE STUDY INVESTIGATOR ASSESSED THIS EVENT WAS NOT RELATED TO THE DA VINCI DEVICES BUT RELATED TO THE PROCEDURE. THE ADVERSE EVENT WAS ASSESSED AS CLAVIEN-DINDO GRADE IIIA. THE INITIAL PROCEDURE WAS COMPLETED WITHOUT INTRA-OPERATIVE COMPLICATIONS REPORTED. THERE WAS NO REPORT OF MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE PROCEDURE." }, { "mdr_text_key": "334552193", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. A REVIEW OF THE SYSTEM LOG REVEALED NO RELATED SYSTEM ERRORS OCCURRING DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. ." } ], "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": "" } ] }