{ "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": "2955842-2026-21101", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260410", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260224", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20260410", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "900223", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260410", "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": "400180-14", "catalog_number": "400180", "lot_number": "K16250731", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260401", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/27/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260717", "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": "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": "20260501", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24839715", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260317", "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": "400465254", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND THE REPORTED EVENT WITH THE INSTRUMENT COULD NOT BE REPLICATED OR CONFIRMED. THE INSTRUMENT WAS VISUALLY INSPECTED INTERNALLY AND EXTERNALLY, AND NO ISSUE WAS IDENTIFIED. THE INSTRUMENT WAS SENT BACK WITHOUT THE TIP-COVER. NO PRODUCT ISSUE WAS FOUND." }, { "mdr_text_key": "400465255", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "398021248", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER WAS PERFORMED. THE IMAGE APPEARS TO SHOW AN MCS TIP COVER ACCESSORY THAT HAS FALLEN FROM THE INSTRUMENT. THERE DOES NOT APPEAR TO BE ANY OBVIOUS DAMAGE ON THE ACCESSORY." }, { "mdr_text_key": "398021249", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AT THE END OF THE CASE, WHILE THE SURGEON WAS CLOSING THE TROCAR INSERTION SITES, THE STAFF NOTICED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FOR THE MCS INSTRUMENT WAS MISSING. PRIOR TO THE EVENT, THE MCS TIP COVER ACCESSORY WAS REPORTEDLY INSTALLED PROPERLY. IN ADDITION, THE MCS INSTRUMENT FUNCTIONED NORMALLY THROUGHOUT THE ENTIRE PROCEDURE. WHEN THE EVENT OCCURRED, THE STAFF IMMEDIATELY INFORMED THE SURGEON, WHO STOPPED THE PROCEDURE. THE STAFF SEARCHED FOR THE TIP COVER ACCESSORY ON THE INSTRUMENT TABLE, IN THE TRASH, ON THE SURGICAL DRAPES, AND IN THE SURROUNDING AREA. THE SURGEON DECIDED TO REINFLATE THE DIAPHRAGM TO CHECK FOR THE PRESENCE OF THE TIP COVER ACCESSORY INSIDE THE PATIENT'S ABDOMEN. THE TIP COVER ACCESSORY WAS FOUND INSIDE THE ABDOMEN AND REMOVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS SUCCESSFULLY RETRIEVED. THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA AND THE MCS TIP COVER ACCESSORY WAS NOT DIFFICULT TO REACH. AFTER THE MCS TIP COVER ACCESSORY WAS RETRIEVED, THE SURGICAL STAFF INSPECTED THE MCS TIP COVER ACCESSORY, THE MCS INSTRUMENT, AND THE CANNULA, AND DID NOT OBSERVE ANY VISIBLE DAMAGE OR ABNORMALITIES." } ], "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": "05/01/2026" } ] }