{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-00480", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130212", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130213", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "61805", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130212", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A60P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Accessory Incompatible", "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20130212", "sequence_number_treatment": [ "DA VINCI SI SURGICAL SYSTEM, ACCESSORIES AND ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20130114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2957752", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130114", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3137808", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI TRANSORAL ROBOTIC SURGERY (TORS), THE PATIENT SUFFERED A LIP BURN. IT WAS CONFIRMED THAT THE INCORRECT 3-PRONGED GROUNDING PAD WAS USED. THE SITE WAS PHYSICALLY REMOVING THE THIRD PIN IN ORDER TO CONNECT IT TO THE CANNULA. THIS COULD BE A POSSIBLE FAILURE MECHANISM AS THIS WOULD CONSTITUTE AN UNVALIDATED USE OF THE PRODUCT." }, { "mdr_text_key": "10537577", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PHYSICIAN'S ASSISTANTS INDICATED IT WAS BELIEVED THAT THE LIP BURN WAS CAUSED DUE TO THE INCORRECT GROUNDING PAD BEING USED. THE HOSPITAL STAFF HAS SINCE BEEN TRAINED AND THE CORRECT GROUNDING PAD IS BEING USED NOW. THE 5MM CANNULAE WERE USED DURING THE PROCEDURE AND NO INSTRUMENTS WERE REPLACED DURING THE PROCEDURE. THE PHYSICIAN INDICATED THE LIP BURN WAS NOTICED AT THE END OF THE CASE AND NO TREATMENT OTHER THAN OBSERVATION WAS ADMINISTERED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED USING THE DA VINCI SYSTEM AND THE PATIENT RECOVERED AS EXPECTED. INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENT TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARMS TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }