{ "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": "2026-10-13", "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-36693", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20260831", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260805", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260831", "manufacturer_contact_f_name": "Izabel", "device_date_of_manufacturer": "20210419", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2789454", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260831", "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": "380601-44", "catalog_number": "N/A", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260831", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260831", "sequence_number_treatment": [ "da Vinci Instruments and Accessories" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260831", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50519638", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260805", "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": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15623417339", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that during a da Vinci-assisted resection procedure, a piece of an unspecified Grasper instrument's black plastic shaft broke off inside the patient. A fragment fell into the patient and was retrieved during the same procedure. No additional harm or injury to the patient was reported, and the patient remained stable. The procedure was completed as planned." }, { "mdr_text_key": "16123417340", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "The unspecified grasper instrument has not been received for failure analysis evaluation.A review of the provided image was performed. The following additional information was provided: A Single Port (SP) Grasper instrument with a sheath installed was observed lying on a plastic tray. There appears to be a chunk of the black instrument sheath that has separated from the rest of the sheath. No mechanical damage to the instrument shaft was observed.The Single Port (SP) instrument was not specified, so a SP system cart was used. Blank MDR fields:The missing patient information in sections A and B was either unknown, unavailable, not provided, or not applicable.The Expiration Date for Section D4 is not applicable.Field D6 is blank because the product is not implantable.Fields G5 and G7 are not applicable.Field H10 is blank as there are no related report numbers." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }