{ "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": "2955842-2023-20428", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20231117", "manufacturer_address_2": "", "pma_pmn_number": "K140553", "date_of_event": "20231027", "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", "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": "20231117", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "858454", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231117", "brand_name": "DA VINCI", "generic_name": "STAPLER CANNULA", "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": "470375", "catalog_number": "470375", "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": "", "udi_public": "", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20231117", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abrasion", "Bruise/Contusion", "Bone Fracture(s)", "Abrasion", "Bruise/Contusion", "Bone Fracture(s)" ] } ], "distributor_city": "", "date_report": "20231027", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18161451", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231027", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "328420244", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN OBSERVED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON INFORMED THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVES ABOUT RECURRENT INCIDENCES OF PATIENT INJURY INVOLVING THE 12MM CANNULA THAT IS PLACED LATERALLY IN THE 8TH INTERCOSTAL SPACE (ICS) DURING PULMONARY LOBECTOMY CASES. INJURIES INCLUDE PORT SITE BRUISING, ABRASIONS AND HAIRLINE FRACTURES IN 25% OF PATIENTS. PER THE SURGEON, THIS IS DUE TO THE CANNULA RUBBING AGAINST THE RIB (INTERNALLY) ABOVE THE ICS WHEN ANGLING UPWARDS. THIS RECURRENT ISSUE WAS THE FOCUS OF AN INTERNAL STUDY CONDUCTED BY SITE RADIOLOGISTS. ADDITIONALLY, PATIENTS EXPERIENCED POST-OPERATIVE PAIN. DURING FOLLOW UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), IT WAS STATED THAT THE BRUISING AND HAIRLINE FRACTURE IS OCCURRING DESPITE CORRECT USE OF THE REMOTE CENTER CANNULA INDICATORS AND WAS SAID THAT IT WAS TYPICALLY CAUSED BY THE ANGLE NEEDED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) DURING STAPLING." }, { "mdr_text_key": "328420245", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AT THIS TIME, SPECIFIC PROCEDURAL DETAILS SUCH AS EVENT DATES ARE NOT KNOWN; THEREFORE, SYSTEM AND INSTRUMENT LOGS ARE UNABLE TO BE PERFORMED." } ], "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": "" } ] }