{ "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": "2955842-2025-43166", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251103", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250826", "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": "20251103", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200224", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1958224", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251103", "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": "380601-40", "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": "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251103", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "59 YR", "patient_sex": "Female", "patient_weight": "75 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Neuropathy", "Neuropathy" ] } ], "distributor_city": "", "date_report": "20251103", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23453399", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251007", "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": "384228614", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM). AT THE 42-DAY FOLLOW-UP, A NEUROPATHY WAS REPORTED. THE EVENT ONSET DATE HAS BEEN REPORTED AS POST-OPERATIVE DAY #14. THE NEUROPATHY WAS LOCATED BILATERALLY, IN THE RIGHT AND LEFT BREASTS. THE NEUROPATHY PAIN WAS IDENTIFIED BY THE PATIENT AND REPORTED TO THE PLASTICS TEAM THAT SHE WAS UNABLE TO GET AHEAD OF THE PAIN IN HER BREASTS AND ASKED FOR RELIEF. IT WAS DESCRIBED AS \"PERSISTENT, SEARING PAIN LOCALIZED TO THE BREAST AREA ABOVE THE NIPPLE AND INCISION LINE, WHICH WORSENS WITH ACTIVITY. THE PAIN IS CONSTANT, NON-RADIATING, AND NOT ASSOCIATED WITH INCISIONAL SITES. THE SKIN IS NUMB, AND ACTIVITIES SUCH AS WALKING OR CAR RIDES EXACERBATE THE PAIN. THE PAIN DOES NOT RADIATE AROUND THE CHEST WALL, ARMS, OR LEGS.\" THE TISSUE EXPANDERS WERE REPORTED AS UNCOMFORTABLE BUT NOT ATTRIBUTED TO THE CURRENT PAIN. TREATMENT CONSISTED OF REFERRAL TO A PAIN CLINIC AND PRESCRIPTIONS FOR IBUPROFEN, TYLENOL, DICLOFENAC AND GABAPENTIN. A BILATERAL PECS I/II BLOCK IN-CLINIC PROCEDURE WAS SCHEDULED; HOWEVER, THE PATIENT INDICATED THAT THE PRESCRIBED MEDICATIONS HAD RELIEVED THE PAIN AND CANCELED THE NERVE BLOCK. THE PROCEDURE WAS A TWO-STAGE BILATERAL NSM WITH TISSUE EXPANDERS AND PLACEMENT OF ACELLULAR DERMIS (ADM). BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM PROCEDURE AND AT THE END OF THE RECONSTRUCTION PROCEDURE. BILATERAL DRAINS WERE PLACED, ONE TO EACH BREAST (THE LEFT DRAIN WAS REMOVED 10 DAYS POST-OPERATIVELY AND THE RIGHT DRAIN WAS REMOVED 13 DAYS POST-OPERATIVELY). THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED THE SAME DAY WITHOUT ANY POST-OPERATIVE COMPLICATIONS. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT (SAE), POSSIBLY RELATED TO THE DA VINCI STUDY DEVICE, POSSIBLY RELATED TO THE NSM STUDY PROCEDURE, POSSIBLY RELATED TO THE NSM RECONSTRUCTION PROCEDURE, BUT NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITIONS." }, { "mdr_text_key": "384228615", "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. ADDITIONAL PATIENT INFORMATION: HEIGHT = 175 CM." } ], "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": "" } ] }