{ "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": "2955842-2026-20946", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260410", "manufacturer_address_2": "", "pma_pmn_number": "K133845", "date_of_event": "20260318", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "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": "", "date_added": "20260411", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "904641", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260410", "brand_name": "DA VINCI", "generic_name": "CANNULA 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": "470361", "catalog_number": "470361", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260416", "health_professional": "Y", "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": "20260410", "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": "20260409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24842461", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260318", "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": "398157847", "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": "398157848", "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 RUBBER PIECE FROM A CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE RUBBER PIECE BUT WAS NOT SURE IF ALL FRAGMENTS WERE RETRIEVED. AN X-RAY WAS BEING PERFORMED; HOWEVER, THE RESULTS OF THE RADIOLOGICAL TEST ARE UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A SLIGHT DELAY AND THERE WAS NO KNOWN INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL WAS VISUALLY INSPECTED BEFORE USE, WITH NO DAMAGE OR ABNORMALITIES NOTED; HOWEVER, THE INTERNAL COMPONENTS OF THE CAP COULD NOT BE EXAMINED DUE TO PACKAGING CONSTRAINTS. THE RUBBER FRAGMENT WAS DISCOVERED INCIDENTALLY AT THE END OF THE ROBOTIC SURGERY, AS THE ARMS AND SPONGES WERE REMOVED AND THE CHEST WALL WAS INSPECTED. THE SURGEON COULD NOT DETERMINE THE EXACT CAUSE OF THE FRAGMENTATION, NOTING THAT THE PROCEDURE WAS ROUTINE AND THAT ONLY ONE PORT SHOWED EVIDENCE OF MISSING MATERIAL. THE ACCESSORY WAS USED THROUGHOUT THE ENTIRE SURGERY, WHICH LASTED APPROXIMATELY FOUR AND A HALF HOURS, AND NO FUNCTIONAL ISSUES WERE OBSERVED DURING THE PROCEDURE. THERE WERE NO OBVIOUS COLLISIONS INVOLVING THE CANNULA SEAL. THE TEAM ATTEMPTED TO RETRIEVE ALL FRAGMENTS BY A THOROUGH INSPECTION AND IMAGING, BUT COULD NOT CONFIRM COMPLETENESS DUE TO INABILITY TO FULLY OPEN THE CAP. NO ADDITIONAL SURGERY WAS NEEDED, THE PROCEDURE WAS COMPLETED AS PLANNED, AND NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN IF THE PATIENT HAS EXPERIENCED ANY POST-SURGICAL COMPLICATIONS." } ], "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": "" } ] }