{ "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": "2955842-2012-00706", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20121027", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20121002", "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": "20121031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121027", "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": "DA", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20121027", "sequence_number_treatment": [ "DAVINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "51", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20130312", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2807220", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130312", "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": "20638008", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER OF A SUCCESSFUL DAVINCI S HYSTERECTOMY W/SACROCOLPOPEX PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE TROCARS FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED SUPERFICIAL BURNS AT THE PORT SITE INCISIONS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE OR TREATMENT FOR THE BURNS. NO ADDITIONAL PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED." }, { "mdr_text_key": "20966119", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI CONTACTED INITIAL REPORTER, NURSE (B)(6), AND SHE INDICATED THERE WERE NO REPORTED MALFUNCTIONS OF THE DAVINCI S SYSTEM, OR INSTRUMENTS/ACCESSORIES DURING THE SURGICAL PROCEDURE. (B)(6) INDICATED THAT ALL OF THE CAUTERY INSTRUMENTS USED DURING THE SURGICAL PROCEDURE WERE TESTED ON (B)(6) 2012 TO VERIFY FOR A BREACH IN THE INSTRUMENT'S INSULATION. TESTING FOUND THAT THERE WERE NO ISSUES WITH THE CAUTERY INSTRUMENTS. (B)(6) ALSO INDICATED THAT THE GROUNDING PAD WAS POSITIONED ON THE PATIENT'S LEFT THIGH AND THE ELECTROSURGICAL UNIT USED WAS A VALLEY LAB DEVICE; HOWEVER, SHE DOES NOT RECALL WHAT MODE AND POWER SETTINGS WERE USED DURING THE SURGICAL PROCEDURE. INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENTS TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARMS TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED. HOWEVER, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DEFINITIVELY DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS 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": "03/16/2013" } ] }