{ "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": "2955842-2014-05893", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141219", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20141121", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141222", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "835590", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141219", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P8", "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": [ "Self-Activation or Keying" ], "reporter_state_code": "ME", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20141219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Injury" ] } ], "distributor_city": "", "date_report": "20141121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4348273", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141121", "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": "12615029", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE INJURY EXPERIENCED BY THE PATIENT. AFTER THE EVENT OCCURRED, AN FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE. THE DA VINCI SURGICAL SYSTEM ((B)(4)) INVOLVED WITH THIS REPORTED EVENT HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES AND THERE HAVE NO SUBSEQUENT OR ADDITIONAL REPORTED COMPLAINTS AGAINST THE SYSTEM. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED THE PATIENT'S INTRA-OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INTRA-OPERATIVE COMPLICATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE INJURY IS UNKNOWN." }, { "mdr_text_key": "5198656", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI NISSEN FUNDOPLICATION PROCEDURE PERFORMED ON (B)(6) 2014, THE SURGICAL STAFF INDICATED THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT AUTO-FIRED AND BURNED THE PATIENT'S TISSUE. THE INITIAL REPORTER INDICATED THAT NO CAUTERY ICONS WERE SEEN WHEN THE EVENT OCCURRED. THE INITIAL REPORTER ALSO INDICATED THAT THE ELECTROSURGICAL UNIT (ESU) GAVE A TONE AND FIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. SHE STATED THAT THE SURGEON WAS SEATED AT THE SURGEON SIDE CONSOLE (SSC) BUT WAS NOT PRESSING ANY BUTTONS OR PEDALS WHEN THE EVENT OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE HEPATIC BRANCH OF THE VAGUS NERVE WAS CUT, SEVERED, AND BURNT. THE SURGEON DID NOT ATTEMPT TO REPAIR THE INJURY. THE INITIAL REPORTER STATED THAT THE SURGICAL STAFF REPLACED THE ESU AND SUCCESSFULLY COMPLETED THE DA VINCI SURGICAL PROCEDURE USING THE SAME FENESTRATED BIPOLAR FORCEP INSTRUMENT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE AT THE SITE. THE INITIAL REPORTER ALSO STATED THAT THERE HAVE BEEN NO REPORTS OF ANY POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. AN ISI FIELD SERVICE ENGINEER (FSE) EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE EXPERIENCED BY THE SURGICAL STAFF. THE SITE'S BIOMED DEPARTMENT HAS EVALUATED THE ESU THAT WAS SWAPPED DURING THE SURGICAL PROCEDURE AND HAS NOT FOUND ANY ISSUES WITH THE ESU AT THIS TIME. THE BIOMED DEPARTMENT WILL BE CONDUCTING FURTHER EVALUATION OF THE ESU." } ], "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": "" } ] }