{ "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": "2955842-2022-12576", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220629", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210309", "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": "20220630", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "957408", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220629", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-05", "catalog_number": "480440", "lot_number": "NA", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20220629", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20210311", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14861505", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210311", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "295125526", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THERE WAS A, ¿PORT SITE TROCAR BURN¿. THE ISSUE WAS FOUND WHEN UNDOCKING THE SYSTEM ARM AND THE SURGEON STARTED TO, ¿SUTURE-CLOSE¿ THE PORT SITE. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR, THE SURGEON SAID INSTRUMENTS WORKED AS EXPECTED AND AS INTENDED BUT THEN SAW THE PORT SITE TISSUE BURN AND COULD NOT EXPLAIN WHAT CAUSED IT. IT WAS UNKNOWN WHICH PORT SITE WAS INVOLVED WITH THE EVENT AND THE SEVERITY THE PORT SITE BURN. HOWEVER; THE BURN WAS DESCRIBED AS BEING, ¿A DARK CIRCLE OF BURNT SKIN AROUND ONLY ONE OF THE PORTS SITES AND IT WAS ABOUT 2MM WIDE¿ FOR WHICH THE SURGEON EXCISED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INTRA-OPERATIVE COMPLICATIONS, NO OBSERVED INSTRUMENT ARCING, NO OBSERVED INSTRUMENT THERMAL DAMAGE, AND NO SYSTEM ERRORS. THE PATIENT WAS REPORTED DOING WELL. SITE HISTORY REVIEW WAS CONDUCTED ON (B)(6) 2021, AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT SYSTEM ERROR LOG REVIEW WAS CONDUCTED ON (B)(6) 2021, THERE WERE NO OBSERVED EVENTS THAT WOULD SUGGEST A PRODUCT ISSUE, ALL LOGGED EVENTS WERE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A ¿PORT SITE BURN¿ ABOUT 2MM WIDE¿ WHICH WAS OBSERVED UPON \"SUTURE-CLOSE\" FOR WHICH THE SURGEON EXCISED. AT THIS TIME, COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THIS RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION RELATED TO THIS COMPLAINT IS OBTAINED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION." }, { "mdr_text_key": "295125527", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THERE WAS A ¿PORT SITE TROCAR BURN¿. THE ISSUE WAS FOUND WHEN UNDOCKING THE SYSTEM ARM AND THE SURGEON STARTED TO ¿SUTURE-CLOSE¿ THE PORT SITE. THE BURN WAS IN THE SHAPE OF A CIRCLE ABOUT 2MM WIDE ALL AROUND THE PORT SITE. THE SURGEON EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE. THE PROCEDURE WAS REPORTEDLY COMPLETED ROBOTICALLY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON REPORTEDLY DID NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR, BUT THE SURGEON DID STATE THAT ALL INSTRUMENTS WORKED AS EXPECTED AND AS INTENDED BUT THEN NOTICED THE PORT SITE TISSUE BURN AND COULD NOT EXPLAIN WHAT CAUSED IT. THE PORT IN WHICH THE SYNCHROSEAL (SS) INSTRUMENT WAS USED WAS UNKNOWN. IT WAS ALSO UNKNOWN WHICH PORT SITE WAS INVOLVED WITH THE EVENT. WHILE THE SEVERITY OF THE PORT SITE BURN WAS UNKNOWN, THE BURN WAS DESCRIBED AS ¿A DARK CIRCLE OF BURNT SKIN AROUND ONLY ONE OF THE PORT SITES AND IT WAS ABOUT 2MM WIDE¿ FOR WHICH THE SURGEON ¿EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE AS USUAL¿. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INTRA-OPERATIVE COMPLICATIONS, NO OBSERVED INSTRUMENT ARCING OR INSTRUMENT THERMAL DAMAGE, AND NO SYSTEM ERRORS REPORTED. THE PATIENT WAS REPORTED AS DOING WELL POST-OPERATIVELY. THERE IS NO EVIDENCE OR ALLEGATION THAT A MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED." } ], "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": "" } ] }