{ "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": "2955842-2015-00428", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150313", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150212", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150313", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "173366", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150313", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20150313", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Full thickness (Third Degree) Burn" ] } ], "distributor_city": "", "date_report": "20150212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4600303", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150212", "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": "17704286", "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 OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT A FEW SYSTEM ERROR CODE 31009'S OCCURRED DURING THE SURGICAL PROCEDURE. A SYSTEM ERROR CODE 31009 IS AN INFORMATIONAL MESSAGE THAT INDICATES THAT A TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. IN ADDITION THE SYSTEM LOGS SHOW THAT THE MCS INSTRUMENT USED DURING THE PROCEDURE INVOLVED WITH THIS COMPLAINT WAS USED IN 5 SUBSEQUENT DA VINCI SURGICAL PROCEDURES. NO ISSUES INVOLVING THE MCS INSTRUMENT WERE REPORTED TO ISI DURING THAT TIME. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: BURNED TISSUE WAS FOUND AROUND A SINGLE CANNULA PORT SITE AT THE COMPLETION OF A DA VINCI SURGICAL PROCEDURE. THE BURNED TISSUE WAS EXCISED BY THE SURGEON AND THE PORT SITE WAS CLOSED. HOWEVER, AT THIS TIME, THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "17575094", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE SKIN AROUND ONE OF THE CANNULA PORT SITES WAS BURNED. ACCORDING TO THE INITIAL REPORTER, THE SITE'S ROBOTICS COORDINATOR, THE SKIN AROUND THE CANNULA ON THE PATIENT'S RIGHT SIDE WAS CHARRED. ON (B)(6) 2015, A TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS INSPECTED THE DA VINCI SURGICAL SYSTEM AND PERFORMED AN ELECTRICAL SAFETY TEST ON THE PATIENT SIDE CART (PSC). NO ISSUES WERE FOUND DURING THE TEST. THE TFS TESTED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT (PART 420179; LOT N10141202-002) THAT WAS USED DURING THE SURGICAL PROCEDURE. THE TFS WAS UNABLE TO DUPLICATE ANY ISSUE OF ENERGY ARCING FROM THE INSTRUMENT AND DID NOT FIND ANY DEFECTS WITH THE DEVICE. NO PARTS WERE REPLACED. THE TFS VERIFIED THAT THE DA VINCI SURGICAL SYSTEM WAS READY FOR USE. THE TFS ALSO MONITORED THE DA VINCI SURGICAL SYSTEM DURING SEVERAL SUBSEQUENT PROCEDURES AND THERE WERE NO RECURRENCES OF THE REPORTED PORT SITE BURN ISSUE. ACCORDING TO THE TFS, THE SITE REPLACED THE FORCE FX ELECTROSURGICAL UNIT (ESU) THAT WAS USED DURING THE PROCEDURE AND THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE ROBOTICS COORDINATOR WAS PRESENT DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ARCING OR INTRA-OPERATIVE COMPLICATIONS OBSERVED. ACCORDING TO THE ROBOTICS COORDINATOR, AT THE END OF THE CASE WHILE THE SURGICAL STAFF WAS REMOVING THE INSTRUMENTS AND CANNULAS, BLACKENED TISSUE WAS FOUND AROUND A CANNULA PORT SITE ON THE PATIENT'S RIGHT SIDE. NO TISSUE SAMPLES WERE OBTAINED AND NO PICTURES WERE TAKEN. THE SURGEON EXCISED THE BLACKENED TISSUE AND SEALED THE PORT. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THE ROBOTICS COORDINATOR INDICATED THAT A VESSEL SEALER INSTRUMENT AND A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WERE USED THROUGH THE CANNULA PORT DURING THE SURGICAL PROCEDURE. THERE WERE NO ISSUES OBSERVED WITH EITHER INSTRUMENT DURING THE PROCEDURE. THE SURGEON WAS USING A VALLEY LAB ELECTROSURGICAL UNIT (ESU) WITH 40-40 SETTINGS." } ], "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": "" } ] }