{ "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": "2955842-2025-47363", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251204", "manufacturer_address_2": "", "pma_pmn_number": "K140553", "date_of_event": "20251111", "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": "408", "date_added": "20251204", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1100822", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251204", "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": "470380", "catalog_number": "470380", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/04/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260122", "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": "20251204", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "50 YR", "patient_sex": "Male", "patient_weight": "102 KG", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20251219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23720733", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251112", "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": "390897001", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390897002", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 4-DEC-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THERE WAS ONE INSTANCE OF CANNULA SEAL TEARING REPORTED ON 11-NOV-2025, AND THERE IS NO RECORD OF ANOTHER INSTANCE OCCURRING ON 12-NOV-2025. REGARDING THE EVENT ON 11-NOV-2025, THE ACCESSORY WAS NOT INSPECTED PRIOR TO USE, SO NO PRE-EXISTING DAMAGE OR ABNORMALITIES WERE IDENTIFIED OR NOTED. IT IS UNCLEAR AT WHICH EXACT SURGICAL TASK THE DEVICE FRAGMENT BROKE OFF, AS THE TIMING OF THE FRAGMENT'S DETACHMENT COULD NOT BE DETERMINED. THE ACCESSORY HAD BEEN IN USE FOR APPROXIMATELY ONE HOUR DURING THE SURGICAL PROCEDURE. THE FRAGMENT WAS DISCOVERED AT THE CONCLUSION OF THE PROCEDURE DURING ROUTINE INSPECTION OF THE ABDOMINAL CAVITY AND IMMEDIATELY PRIOR TO REMOVAL OF THE ROBOTIC INSTRUMENTS FOR UNDOCKING. THROUGHOUT THE SURGERY, THE SURGEON DID NOT NOTICE ANY FUNCTIONAL ISSUES WITH THE ACCESSORY, AND THERE WERE NO COLLISIONS BETWEEN THE INSTRUMENT AND OTHER INSTRUMENTS. THE FRAGMENT DID NOT RESULT FROM A COLLISION; IT WAS IDENTIFIED DURING NORMAL HANDLING." }, { "mdr_text_key": "386782577", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "386782578", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A PIECE OF THE RUBBER VALVE FROM THE CANNULA SEAL BROKE OFF AND WAS FOUND INSIDE THE PATIENT. THE CAUSE OF THE INCIDENT IS UNKNOWN; HOWEVER, IT WAS NOTED THAT THERE WAS SOME REPORTED RESISTANCE DURING INSERTION. THE FRAGMENT WAS RETRIEVED WITHOUT ISSUE USING A ROBOTIC INSTRUMENT, THOUGH THE SPECIFIC INSTRUMENT WAS NOT IDENTIFIED. THE PATIENT WAS DISCHARGED THE SAME DAY AND HAS A SCHEDULED FOLLOW-UP CONSULTATION WITH THE SURGEON IN TWO WEEKS. THE REPORTER, WHO WAS NOT PRESENT DURING THE SURGERY, IS UNSURE WHAT HAPPENED TO THE RETRIEVED PIECE. THE PROCEDURE WAS COMPLETED." } ], "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": "12/19/2025" } ] }