{ "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": "2026-09-22", "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": "2955842-2012-00137", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120330", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20120402", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120330", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC 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": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "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": [ "Overheating of Device" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20120330", "sequence_number_treatment": [ "DA VINCI S SURG SYS INST., ACCESSORIES,& ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20111123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2511990", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20111127", "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": "2572261", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S NISSEN FUNDOPLICATION PROCEDURE, THE SURGICAL STAFF OBSERVED THE BIPOLAR INSTRUMENT TO HAVE ENERGIZED WITHOUT THE FOOTPEDAL BEING PRESSED RESULTING IN A BURN TO THE PATIENT'S LIVER. THE BIPOLAR INSTRUMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING REPLACEMENT INSTRUMENTS. THE SITE REPORTED THAT THE PATIENT IS DOING FINE; HOWEVER, IT IS UNKNOWN IF OR HOW THE PATIENT WAS TREATED. AN ERROR IN THE INITIAL REVIEW OF THIS EVENT RESULTED IN A DELAY OF THE SUBMISSION OF THIS REPORT." }, { "mdr_text_key": "9704717", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONCLUDED THAT THE PATIENT INJURY WAS RELATED TO A SETUP ISSUE WITH THE ELECTRICAL SURGICAL UNIT (ESU) WHICH IS NOT SUPPLIED BY INTUITIVE SURGICAL. THE SURGICAL STAFF ADVISED THAT THE ROOT CAUSE OF THIS EVENT WAS RELATED TO THE BIPOLAR CABLE BEING REMOVED FROM THE ESU UNIT. THE ESU WAS SET INCORRECTLY TO AUTO BIPOLAR MODE AND WHEN THE BIPOLAR CABLE WAS RE-CONNECTED THE INSTRUMENT BEGAN TO ACTIVE AS WOULD BE INTENDED WITH THESE ESU SETTINGS. FURTHER TESTING FROM THE SITE DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WAS WORKING TO SPECIFICATIONS AND DID NOT CONTRIBUTE TO THIS EVENT. AS OF (B)(4), 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." } ], "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": "" } ] }