{ "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": "2955842-2026-05346", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260226", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260202", "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": "SP", "manufacturer_contact_area_code": "", "date_added": "20260226", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "516005", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260226", "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": "UNKNOWN", "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": [ "Thermal Decomposition of Device", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/01/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260505", "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": "20260226", "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": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20260422", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24461528", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260202", "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": "394154175", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY AND MCS INSTRUMENT HAVE NOT BEEN RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS. IMAGES PROVIDED BY THE CUSTOMER OF THIS EVENT WERE REVIEWED. THE IMAGES SHOW AN MCS TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT WITH A VISIBLE BURN DEFECT, CHAR, AND GOUGES. FROM THE IMAGES IT IS DIFFICULT TO SAY FOR SURE IF THE GOUGES GO THROUGH THE ACCESSORY. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT#: 2955842-2026-05347 FOR MDR SUBMISSION OF THE EVENT REPORTED AGAINST THE OTHER MCS TIP COVER ACCESSORY." }, { "mdr_text_key": "394154176", "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 MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ARCED, CAUSING A BURN ON THE MCS TIP COVER ACCESSORY AND THE SMALL INTESTINE. THE SURGEON PLACED A \"SAFETY STITCH\" DUE TO THE REPORTED SUPERFICIAL BURN(S) ON THE SMALL INTESTINE. THIS EVENT OCCURRED DURING DISSECTION WHILE THE SURGEON WAS USING COAG ENERGY WITH THE MCS INSTRUMENT. IT WAS REPORTED THAT THIS EVENT OCCURRED WITH TWO DIFFERENT MCS TIP COVER ACCESSORIES. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED. THE E-200 GENERATOR WAS BEING USED TO SUPPLY ENERGY DURING THIS PROCEDURE. THE GROUNDING PAD DID NOT APPEAR TO HAVE ANY ISSUES/DEFECTS. THE BURNS WERE DISCOVERED IN THE LAST 30 MINUTES OF THE SURGERY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE MCS INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR TOUCH STAPLES OR CLIPS WHILE ENERGIZED. ADDITIONALLY, THE MCS INSTRUMENT WAS NOT IMMERSED IN LIQUIDS WHEN THE EVENT OCCURRED. THE MCS INSTRUMENT WAS REPLACED AND THE PROCEDURE WAS COMPLETED AS PLANNED." }, { "mdr_text_key": "399104947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G6, H2. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE TIP COVER ACCESSORY. INTUITIVE RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE TIP COVER ACCESSORY WAS NOT SENT WITH THE INSTRUMENT. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN, WITH A NEW TIP COVER ACCESSORY, ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE BLADES OPENED AND CLOSED PROPERLY SEVERAL TIMES. THE CUT TEST WAS DONE THREE TIMES AND PASSED EACH TIME. THE MONOPOLAR ENERGY CORD WAS CONNECTED TO AN IN-HOUSE GENERATOR AND PASSED RECOGNITION AS AN ENERGY DEVICE. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE NEW, TEST TIP COVER ACCESSORY DID NOT SHOW THERMAL DAMAGE. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "399104948", "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/22/2026" } ] }