{ "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": "2955842-2023-20022", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20231106", "manufacturer_address_2": "", "pma_pmn_number": "K140553", "date_of_event": "20231006", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231106", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "351687", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231106", "brand_name": "DA VINCI", "generic_name": "SEAL", "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": "470380-09", "catalog_number": "470380", "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": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20231106", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "54 YR", "patient_sex": "Male", "patient_weight": "90 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231009", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18078198", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231009", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "327476625", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE BLUE PART OF THE CANNULA SEAL BROKE OFF INSIDE THE PATIENT WHEN A REDUCER WAS INSERTED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE TROCAR APPEARED NORMAL. A PIECE OF THE CANNULA SEAL WAS IDENTIFIED PRIOR TO THE CONCLUSION OF THE CASE, INCIDENTALLY. THE SURGEON BELIEVES THE REDUCER PLACED THROUGH THE 12MM BROKE OFF A PIECE OF THE CANNULA SEAL WHICH FELL INSIDE THE PATIENT'S ABDOMEN. THE TROCAR WAS USED THE ENTIRE CASE, BUT AIRSEAL (A 3RD PARTY MANUFACTURER PRODUCT) WOULD NOT WORK CORRECTLY ON THE AFFECTED 12MM TROCAR. THERE WERE NO DEVICE COLLISIONS AND NO INSTRUMENTS WERE REMOVED PRIOR TO BREAKAGE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT THROUGH THE CANNULA. THE FRAGMENT WAS INSPECTED AND IDENTIFIED AS THE ONLY BROKEN OFF PIECE. THERE WERE NO ADDITIONAL PROCEDURES, AND NO POST-OPERATIVE TESTS DONE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT DID NOT RETURN TO THE HOSPITAL. THE TROCAR AND PIECE WERE SAVED AND SENT FOR EVALUATION." }, { "mdr_text_key": "327476626", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE CANNULA SEAL TO PERFORM FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. AN IMAGE OF THE CANNULA SEAL INVOLVED WITH THE REPORTED EVENT WAS PROVIDED BY THE CUSTOMER AND REVIEWED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, THE IMAGE APPEARS TO SHOW A 12MM CANNULA SEAL WITH A TORN SEPTUM. A REVIEW OF THE SYSTEM LOGS DOES NOT REVEAL ANY RELATED ERRORS OCCURRED DURING THE REPORTED EVENT." } ], "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": "" } ] }