{ "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": "2955842-2025-08143", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250327", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250227", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250327", "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": "1537718", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250327", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "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": "", "device_evaluated_by_manufacturer": "N", "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": "US", "date_changed": "20250825", "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": "20250327", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "38 YR", "patient_sex": "Female", "patient_weight": "68 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20250228", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21712344", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250228", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "366877190", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE REMOTE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME." }, { "mdr_text_key": "366877191", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. A SMALL SUPERFICIAL BURN WAS NOTED ON THE LEFT AREOLA PRIOR TO INCISION CLOSURE. CAREFUL INSPECTION OF THE FLAPS WAS PERFORMED IN ORDER TO ENSURE THAT THIS WAS NOT A THERMAL INJURY FROM THE DISSECTION AND THIS WAS CONFIRMED. THIS APPEARED TO BE A MILD SUPERFICIAL DESQUAMATION BURN MEASURING APPROXIMATELY 4 X 4 MM IN SIZE. AFTER THE COMPLETION OF THE OPERATION, A SMALL DRESSING WAS PLACED AT THIS SITE. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THAT THE EVENT WAS MILD IN SEVERITY, WAS POSSIBLY RELATED TO THE NIPPLE SPARING MASTECTOMY PROCEDURE AND A DA VINCI STUDY DEVICE, AND THAT IT OCCURRED AFTER THE UNDOCKING OF THE DA VINCI SYSTEM. ON 04-MAR-2025, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PHYSICIAN: THE CAUSE OF THE BURN IS UNCLEAR. HOWEVER, THE PHYSICIAN BELIEVES THE COMPLICATION WAS LIKELY FROM AN INADVERTENTLY PLACED INSTRUMENT ON THE PATIENT DURING THE PLASTIC SURGERY PORTION OF THE OPERATION. THE BURN WAS CONFIRMED TO NOT BE PRESENT AT THE COMPLETION OF THE ROBOTIC PORTION OF THE OPERATION AND AGAIN CONFIRMED TO NOT BE PRESENT AT THE COMPLETION OF THE OPERATION. UPON INQUIRING WITH THE PLASTIC SURGERY TEAM, NO ONE COULD RECALL A PARTICULAR INSTRUMENT THAT WOULD HAVE RESULTED IN THE COMPLICATION AND THEREFORE, ADDITIONAL DETAILS ARE UNABLE TO BE PROVIDED. THERE WAS NO ARCING OR SPARKS OBSERVED COMING FROM ANY OF THE INSTRUMENTS AND THERE WERE NO DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE SKIN BURN. THE PATIENT IS HEALTHY WITH NO MEDICAL COMORBIDITIES AND THERE ARE NO RELEVANT TESTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }