{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-12290", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220623", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20110101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20220623", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "264861", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220623", "brand_name": "DA VINCI", "generic_name": "DA VINCI XI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220623", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "48 YR", "patient_sex": "Female", "patient_weight": "50 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20201126", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14787358", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201126", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "295046056", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) \"IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED.\" ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: \"WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY UNLIKE THE 2D RIGID ANGLED SCOPE, AS THE ROTATION OF THE SCOPE WAS RESTRICTED. MOREOVER, THE INTERFERENCE OF THE ARMS OUTSIDE THE PATIENT BODY MAY HINDER THE LATERAL POSITIONING OF THE SCOPE ARM. TAPING THE OBJECT TO BE STAPLED TO SECURE AND CONFIRMING THE TIP OF THE STAPLER IS A SIMPLE AND EFFECTIVE METHOD TO ADDRESS THE PROBLEM.\" ON 05-MAY-2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE OCCURRED IN 2011. THE PRECISE DATE WAS NOT AVAILABLE. THE INCIDENT SHOULD BE ATTRIBUTED TO THAT THE SURGEONS WERE NOT FAMILIAR WITH THE CHARACTER OF THE ROBOT SYSTEM. THE SURGEON CONFIRMED THAT THE BLEEDING OCCURRED FROM THE LINGUAL SEGMENTAL PULMONARY ARTERY. THE BLOOD LOSS WAS MEASURED AT LESS THAT 900ML. A BLOOD TRANSFUSION WAS ADMINISTERED, THE EXACT AMOUNT OF BLOOD TRANSFUSED IS UNKNOWN. THE SURGEON BELIEVES THAT THE CAUSE OF THE POST-OPERATIVE COMPLICATION(S) WAS PAIN, DUE TO THORACOTOMY. THE SURGEON CONFIRMED THAT DUE TO POST-OPERATIVE COMPLICATION(S) THE PATIENT WAS ADMINISTERED PAIN MEDICATION. ADMINISTERED MEDICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT." }, { "mdr_text_key": "295046057", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME BECAUSE OF INSUFFICIENT PRODUCT INFORMATION. THE EVENT DATE IS UNKNOWN AND A REVIEW OF THE SITE'S COMPLAINT HISTORY CANNOT BE PERFORMED TO IDENTIFY RELATED/DUPLICATE COMPLAINTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW AND NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT SUSTAINED AN INJURY FROM THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE. CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED. THE CAUSE OF THE CONVERSION WAS FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. IT WAS REPORTED THAT A BLOOD TRANSFUSION WAS ADMINISTERED, THE EXACT AMOUNT OF BLOOD TRANSFUSED IS UNKNOWN. IT IS ALSO UNKNOWN WHAT SUBSEQUENT ACTIONS WERE TAKEN TO CONTROL THE PATIENTS BLEEDING. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }