{ "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": "2955842-2025-30372", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250718", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250627", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250718", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231027", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "602208", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250718", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "470500-13", "catalog_number": "470500", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/12/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251128", "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": "20250718", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20250627", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22540714", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250627", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "375246027", "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 BLACK RUBBER ON THE TROCAR CAPS BREAKING OFF AND FALLING INSIDE OF THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE." }, { "mdr_text_key": "375246028", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE CANNULA SEAL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "384249907", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "384249908", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A TOTAL OF 4 DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS UNDER THIS RECORD. THE 4 UNIVERSAL SEALS WERE ANALYZED BY THE FAILURE ANALYSIS (FA) TEAM BUT ONLY 1 OF THEM EXHIBITED THE REPORTED CONDITION. THE UNIVERSAL SEAL #1 WAS FOUND TO HAVE A PIECE OF THE BLACK RUBBER DUCKBILL TORN. THE TORN PIECE WAS NOT RETURNED WITH THE SEAL. THE UNIVERSAL SEAL #2 WAS ANALYZED BUT THE REPORTED ISSUE COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION FOUND NO DAMAGE TO THE SEAL. THE DUCKBILL WAS INTACT, AND THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO PROBLEM DETECTED. THE UNIVERSAL SEAL #3 WAS ANALYZED BUT THE REPORTED ISSUE COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION FOUND NO DAMAGE TO THE SEAL. THE DUCKBILL WAS INTACT, AND THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO PROBLEM DETECTED. THE UNIVERSAL SEAL #4 WAS ANALYZED BUT THE REPORTED ISSUE COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION FOUND NO DAMAGE TO THE SEAL. THE DUCKBILL WAS INTACT, AND THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO PROBLEM DETECTED." } ], "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": "09/11/2025" } ] }