{ "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": "2955842-2022-13817", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220902", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20220804", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220902", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "435182", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220902", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "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": "", "device_evaluated_by_manufacturer": "R", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220902", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20220804", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15351467", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220804", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "299208329", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS NOT RECEIVED THE INSTRUMENT OR ACCESSORY INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AN INSTRUMENT LOG REVIEW WAS ALSO PERFORMED. THE SURGEON USED TWO MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS (PART #470179-19; LOT #S K10220411-0442 AND K10220411-0444) DURING THE CASE. PER THE INSTRUMENT LOGS, THE MCS INSTRUMENT WITH LOT #K10220411-0444 WAS USED IN A SUBSEQUENT SURGICAL PROCEDURE. THE MCS INSTRUMENT WITH LOT #K10220411-0442 HAS NOT BEEN USED IN A SUBSEQUENT SURGICAL PROCEDURE. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALS NO COMPLAINTS REPORTED AGAINST ANY OF THE INSTRUMENTS USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE SURGEON NOTICED CAUTERIZED TISSUE WHERE ENERGY WAS NOT INTENTIONALLY APPLIED. THE TYPE OF TISSUE THAT WAS UNINTENTIONALLY CAUTERIZED AND THE SEVERITY OF THE BURN ARE UNKNOWN. IT IS ALSO UNKNOWN WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE INTRA-OPERATIVE COMPLICATION. ADDITIONALLY, IT IS UNKNOWN WHAT SPECIFIC INSTRUMENT WAS INVOLVED WITH THE CUSTOMER REPORTED EVENT." }, { "mdr_text_key": "299208330", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, THE SURGEON NOTICED CAUTERIZED TISSUE WHERE ENERGY WAS NOT INTENTIONALLY APPLIED. IT WAS NOTED THAT NOTHING WAS VISIBLY WRONG WITH THE INSTRUMENT. IT IS UNKNOWN WHAT SPECIFIC TISSUE WAS UNINTENTIONALLY CAUTERIZED AND IF ANY MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. ADDITIONALLY, THE SEVERITY OF THE BURN INJURY IS UNKNOWN. FURTHERMORE, IT IS UNKNOWN WHAT SPECIFIC INSTRUMENT WAS INVOLVED WITH THE COMPLICATION. THE SURGICAL PROCEDURE WAS REPORTEDLY COMPLETED WITH NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }