{ "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": "2955842-2013-01336", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130419", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130325", "reprocessed_and_reused_flag": "", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130422", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "170764", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130419", "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": "0", "model_number": "IS3000 A60.P3", "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": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20130419", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130325", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3069280", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130325", "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": "3265310", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNCONTROLLED BLEEDING. THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES." }, { "mdr_text_key": "10731224", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED APPROXIMATELY 5 HOURS INTO THE SURGICAL PROCEDURE, WHILE THE SURGEON WAS TRANSECTING THE PATIENT'S PULMONARY VEIN OR PULMONARY ARTERY TO REMOVE A LOBE, THE SURGEON NOTED THAT THE PATIENT WAS BLEEDING. THE CSR INDICATED THAT THE SPECIFIC VESSEL THAT THE PATIENT WAS BLEEDING FROM IS UNKNOWN, HOWEVER, BASED ON THE LOCATION OF THE ANATOMY THAT THE SURGEON WAS WORKING, HE BELIEVES THAT THE PATIENT WAS BLEEDING FROM A VESSEL BRANCH OF THE PULMONARY VEIN OF THE LEFT UPPER LOBE. THE CSR INDICATED THAT HE DOES NOT RECALL WHICH INSTRUMENTS WERE INSTALLED AT THE TIME THAT THE ISSUE OCCURRED; HOWEVER, THE SURGEON ATTEMPTED TO CONTROL THE PATIENT'S BLEEDING USING ETHICON CLIPS INSTALLED ON AN ETHICON CLIP APPLIER INSTRUMENT USED THROUGH AN ASSIST PORT. THE SURGEON'S ATTEMPT TO CONTROL THE PATIENT'S BLEEDING WAS UNSUCCESSFUL, AND THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES TO CONTROL THE PATIENT'S BLEEDING AND TO COMPLETE THE SURGICAL PROCEDURE. THE CSR INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED WHEN THE ISSUE OCCURRED. THE CSR INDICATED THAT APPROXIMATELY 1 WEEK LATER, HE SPOKE TO THE CIRCULATING NURSE AND SHE INDICATED TO HIM THAT THE PATIENT RECOVERED WELL POST-OPERATIVELY AND WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2013, ISI CONTACTED THE SURGEON REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT UNDERWENT A DA VINCI SI LOBECTOMY PROCEDURE DUE TO T1 STAGE CANCER. THE SURGEON INDICATED THAT TOWARDS THE END OF THE SURGICAL PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE BLEEDING FROM A BRANCH OF THE PULMONARY ARTERY OF THE LEFT UPPER LOBE AND THAT HE ATTEMPTED TO REPAIR THE AFFECTED AREA ROBOTICALLY; HOWEVER, THE VENTILATION TUBE THAT WAS INSERTED INSIDE OF THE PATIENT'S BRONCHUS DISLODGED, CAUSING THE PATIENT'S LUNG TO INFLATE. THE SURGEON INDICATED THAT THE PHYSICIAN'S ASSISTANT AT THE PATIENT SIDE CART EXPERIENCED DIFFICULTY REINSERTING THE VENTILATION TUBE AND DUE TO INFLATION OF THE PATIENT'S LUNG IT WAS DIFFICULT TO VISUALIZE THE SURGICAL AREA TO ALLOW FOR REPAIR OF THE AFFECTED ANATOMY USING THE DA VINCI SURGICAL SYSTEM; THUS HE MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN TO ALLOW FOR REPAIR OF THE AFFECTED VESSEL AND COMPLETION OF THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT HE REPAIRED THE AFFECTED AREA WITH A SUTURE. THE SURGEON DID NOT INDICATE THE CAUSE OF THE BLEEDING EXPERIENCED BY THE PATIENT; HOWEVER, HE INDICATED THAT NO MALFUNCTION OF THE SITE'S DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED WHILE HE WAS PERFORMING THE SURGICAL PROCEDURE AND THE BLEEDING EXPERIENCED BY THE PATIENT WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON INDICATED THAT THE PATIENT'S HOSPITALIZATION WAS NOT PROLONGED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY 5 DAYS POST-OP. THE SURGEON INDICATED THAT HE HAS HAD TWO POST-SURGICAL FOLLOW UP VISITS WITH THE PATIENT AND THE PATIENT IS RECOVERING WELL. BASED ON THE ADDITIONAL INFORMATION PROVIDED CONCERNING THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THE SITE'S DA VINCI SI SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT." } ], "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": "" } ] }