{ "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": "N", "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": "2955842-2026-21286", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20260413", "manufacturer_address_2": "", "pma_pmn_number": "K243582", "date_of_event": "20260320", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20260413", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251215", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "919908", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260413", "brand_name": "DA VINCI", "generic_name": "SP ADVANCED ACCESS PORT", "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": "432701-10", "catalog_number": "432701", "lot_number": "H10251215", "other_id_number": "", "device_availability": "", "date_returned_to_manufacturer": "20260408", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/10/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260902", "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": "20260413", "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": "20260901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24860491", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260323", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "398233428", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLACK RUBBER STOPPER ON THE PORT (COVER) TROCAR PART HAD DETACHED, SO THE ARM COULD NOT BE INSERTED. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. DURING THE PROCEDURE, WHILE INSERTING THE INSTRUMENT, A FRAGMENT BROKE OFF BUT DID NOT FALL INSIDE THE PATIENT DUE TO THE SMALL INCISION - IT LANDED ON THE PORT INSTEAD. THE SURGEON BELIEVES THE BREAKAGE WAS CAUSED BY A DEFECTIVE ACCESSORY, WHICH HAD BEEN IN USE FOR LESS THAN 30 MINUTES. NO COLLISION BETWEEN INSTRUMENT TIPS OR ACCESSORY OCCURRED, AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH ALL PIECES VISUALLY CONFIRMED AS REMOVED. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE IMAGING WAS NECESSARY, AND THE SURGERY WAS COMPLETED ROBOTICALLY WITHOUT ADDITIONAL INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FRAGMENTS. BOTH THE INSTRUMENT AND ACCESSORY, INCLUDING THE RETRIEVED FRAGMENT, ARE AVAILABLE FOR EVALUATION BY ISI, BUT NO PHOTOGRAPHIC OR VIDEO DOCUMENTATION WAS AVAILABLE FOR REVIEW." }, { "mdr_text_key": "398233429", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ACCESSORY ACCESS PORT CHAMBER WAS FOUND TO HAVE THE BLACK RETENTION CAP HEAT STAKING DISTAL SEAL DISLODGED. THE SEAL WAS INSPECTED AND FOUND TO HAVE NO PHYSICAL DAMAGE." } ], "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": "09/01/2026" } ] }