{ "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": "2955842-2025-40945", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251009", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250818", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20251009", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240718", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1067499", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251009", "brand_name": "DA VINCI", "generic_name": "MONOPOLAR CURVED SCISSORS (MCS) TIP", "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": "430035-13", "catalog_number": "430035", "lot_number": "K10240718", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/22/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251009", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251117", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23260333", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250916", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "382180331", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT WITH RECONSTRUCTION NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP WAS SEPARATED FROM THE INSTRUMENT DURING THE PROCEDURE. THE METAL PART AND PLASTIC PART WAS SEPARATED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE SCISSORS TIP ACCESSORY DID FALL INTO THE PATIENT AND WAS RETRIEVED. THE METAL SCISSORS WERE SEPARATED FROM THE PLASTIC COVER OF THE TIP ACCESSORY. THE CUSTOMER DID NOT OBSERVE ANY DAMAGE ON THE SP MONOPOLAR CURVED SCISSOR TUBE ADAPTER AND USED ANOTHER SCISSORS TIP ACCESSORY TO CONTINUE THE CASE." }, { "mdr_text_key": "382180332", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "385444586", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "385445181", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP TO PERFORM FAILURE ANALYSIS. THE MCS TIP WAS ANALYZED AND FOUND TO HAVE A DISLODGED RETAINING TIP COVER FROM THE MCS BLADES. THE RETAINING TIP COVER WAS OBSERVED TO BE COMPLETELY DETACHED FROM THE BLADES. DUE TO THE DISLODGED RETAINING COVER, A DETACHED FRAGMENT, MEASURING APPROXIMATELY 7.20 MM X 13.42 MM IN SIZE, WAS OBSERVED AND RETURNED WITH THE MCS TIP ACCESSORY. THE MCS RETAINING TIP COVER WAS FOUND TO HAVE A CRACKING DAMAGE. NO MATERIAL APPEARS TO BE MISSING." } ], "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": "11/17/2025" } ] }