{ "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": "2955842-2013-00267", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130123", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121228", "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": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130123", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "32328", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130123", "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 A6.0P7", "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": [ "Misfire" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20130123", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20121228", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2927223", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121228", "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": "21757796", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE BIPOLAR INSTRUMENT FIRED UNINTENTIONALLY DURING A PROCEDURE ACCORDING TO THE INFORMATION PROVIDED TO THE CLINICAL SALES REPRESENTATIVE (CSR), THE CUSTOMER ALLEGED THAT WHILE THEY WERE INSTALLING THE BIPOLAR INSTRUMENT TO THE DAVINCI ROBOT SYSTEM, AS THEY CONNECTED THE BIPOLAR INSTRUMENT CABLE TO THE VALLEYLAB GENERATOR, THE ELECTROSURGICAL UNIT (ESU) MADE A FIRING TONE AND THE BIPOLAR INSTRUMENT FIRED. THE INSTRUMENT TIP DID TOUCH THE PATIENT'S UTERUS (WHICH WAS EVENTUALLY REMOVED). ACCORDING TO THE INFORMATION PROVIDED TO THE CSR, THE CUSTOMER WAS ABLE TO SUCCESSFULLY COMPLETE THE CASE PLUS TWO ADDITIONAL CASES USING THE SAME GENERATOR WITH NO FURTHER INCIDENTS." }, { "mdr_text_key": "21891657", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CLINICAL SALES REPRESENTATIVE (CSR) VISITED THE SITE TO VERIFY THAT THE CUSTOMER WAS USING THE CORRECT ELECTROSURGICAL UNIT (ESU), VALLEY LAB FORCE, WITH THE CORRECT ENERGY ACTIVATION CABLE (BLUE VALLEY LAB CABLE). THE CSR CONFIRMED THAT THE EQUIPMENT WAS COMPATIBLE. BASED ON THE ADDITIONAL INFORMATION PROVIDED TO THE CSR BY THE OPERATING ROOM NURSE, NO FURTHER ISSUES HAD OCCURRED AFTER THE CAUTERY CABLE WAS REPLACED. THE CAUTERY CABLE USED DURING THE CASE WAS NOT RETURNED FOR EVALUATION. AS OF (B)(6) 2013, 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": "" } ] }