{ "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": "2955842-2025-49436", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251222", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20251201", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20251222", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "229940", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251222", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180", "catalog_number": "400180", "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 Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/02/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260311", "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": "20251222", "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", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260126", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23865604", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251205", "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": "388266418", "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 MCS TIP COVER ACCESSORY FELL INTO A PATIENT. A FRAGMENT WAS RETIRED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "388266419", "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": "391384001", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY WERE THOROUGHLY INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING UNUSUAL WAS FOUND AT THAT TIME; THEY BOTH APPEARED TO BE IN PROPER CONDITION. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE PROCEDURE USING A COELIO INSTRUMENT. AT THE TIME THE ACCESSORY FELL INSIDE THE PATIENT, THE SURGICAL TASK BEING PERFORMED WAS DISSECTING. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ACCESSORY TO SLIP OFF OR BREAK; NO SPECIFIC CAUSE WAS IDENTIFIED. THE MCS INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY TWO HOURS WHEN THE INCIDENT OCCURRED. THROUGHOUT THE PROCEDURE, THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT, AND THERE WERE NO COLLISIONS BETWEEN THE MCS INSTRUMENT AND ANY OTHER INSTRUMENTS. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE: NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER INSTALLATION, NOR WAS THE ACCESSORY OVER-INSTALLED BEYOND THE ORANGE SURFACE, WHICH MEANS THERE WAS NO BULGING OVER THE SHAFT. THE USUAL REDUCER WAS USED DURING THE PROCEDURE. NO DIFFICULTY WAS ENCOUNTERED WHEN REMOVING THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY, AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. AFTER THE EVENT, THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE MCS TIP COVER ACCESSORY, THE MCS INSTRUMENT, OR THE CANNULA. TO COMPLETE THE PROCEDURE, THE TIP COVER WAS CHANGED, AND THE OPERATION WAS FINISHED ROBOTICALLY WITHOUT NEEDING TO ABORT OR CONVERT TO OPEN OR TRADITIONAL LAPAROSCOPIC SURGERY. THE MCS TIP COVER ACCESSORY IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION, WHEREAS THE MCS INSTRUMENT IS NOT, SINCE IT WAS FUNCTIONING PROPERLY AND CONTINUES TO BE USED." }, { "mdr_text_key": "391384002", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "01/26/2026" } ] }