{ "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": "2955842-2026-20791", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260408", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20260304", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260408", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "875253", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260408", "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", "catalog_number": "470500", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260416", "health_professional": "", "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": "20260408", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260408", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24814991", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260311", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "397760322", "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 CUSTOMER THOUGHT THE BROKEN PIECE WAS CHAR FROM CAUTERY. THE CUSTOMER WAS ABLE TO GRAB IT AND REMOVE IT FROM THE PATIENT. THEY REALIZED IT WAS RUBBERY INSTEAD OF CHAR. AT THE END OF THE CASE THE SURGICAL TECH NOTICED THE SEAL WAS BROKEN WHEN SHE REMOVED IT FROM THE METAL TROCAR. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS VISUALLY INSPECTED FOR SEAL INTEGRITY PRIOR TO USE, BUT THE RUBBER PORTION WAS NOT CLOSELY EXAMINED. THE DEVICE FRAGMENT WAS DISCOVERED ABOUT ONE HOUR INTO THE PROCEDURE DURING INSTRUMENT CHANGES AT A PORT, THOUGH THE EXACT TIMING AND CAUSE OF THE BREAKAGE ARE UNKNOWN AND THE SURGEON DID NOT OFFER A COMMENT, EXCEPT TO REQUEST REPORTING. NO FUNCTIONAL ISSUES OR INSTRUMENT COLLISIONS WERE NOTED BY THE SURGICAL TEAM. FRAGMENTS WERE RETRIEVED BY THE SURGEON, WHO ORIGINALLY THOUGHT THE MATERIAL WAS CHAR, USING AN INSTRUMENT THROUGH THE ACCESSORY PORT, AND THE TEAM WAS FAIRLY CONFIDENT ALL PIECES WERE REMOVED BASED ON THE DEFECT OBSERVED IN THE SEAL, THOUGH THEY COULD NOT VERIFY THIS WITH ABSOLUTE CERTAINTY; NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE IMAGING WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT FURTHER COMPLICATION, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL POST-OPERATIVELY. THE SEAL WAS DISCARDED." }, { "mdr_text_key": "397760640", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SEAL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED. IMAGE SHOWS A CANNULA SEAL WITH A TORN DUCKBILL. THERE APPEARS TO BE A BLACK COLORED DETACHED FRAGMENT SIMILAR IN SIZE AND SHAPE TO THE DUCKBILL TEAR AT THE BOTTOM OF THE IMAGE." } ], "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": "" } ] }