{ "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": "2955842-2022-16257", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230104", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20221111", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20230104", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "908292", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230104", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601-45", "catalog_number": "380601", "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "20250731", "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": "20230104", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "72 YR", "patient_sex": "Male", "patient_weight": "73 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Ecchymosis", "Hemoptysis", "Hemorrhage/Blood Loss/Bleeding", "Ecchymosis", "Hemoptysis", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20221205", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16096922", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20221205", "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": "306640305", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION WAS DUE TO \"MAL-RESECTION,\" ACCORDING TO THE INITIAL REPORTER, USING A 3RD-PARTY STAPLER AND UNUSUAL ANATOMY OF THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES AND A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI ASSISTED RIGHT MIDDLE LOBE PULMONARY LOBECTOMY PROCEDURE, THE PATIENT HAD HEMOPTYSIS AND WAS FOUND TO HAVE A PLEURAL EFFUSION ON X-RAY. AS A RESULT, THE PATIENT UNDERWENT A RE-OPERATION AND THE PLEURAL EFFUSION AS WELL AS THE BLOOD CLOT WERE EVACUATED. THE SURGEON DID FURTHER RE-EXPLORATION AND FOUND AN ECCHYMOSES OF THE POSTERIOR ASCENDING BRANCH (A2) OF THE PULMONARY ARTERY. THE SURGEON USED TWO HEM-O-LOCKS CLIPS AS WELL AS THE HARMONIC SCALPEL TO RESECT THE A2 BRANCH. THE SURGEON BELIEVES THAT THE SUSPECTED CAUSE OF THE POST-OPERATIVE COMPLICATION WAS UNCOMMON ANATOMY CAUSING BLOOD FROM THE UPPER LOBE TO FLOW BACK TO THE MIDDLE LOBE, RESULTING IN THE BLOOD CLOT. THE SUSPECTED DEVICE INVOLVED IN CAUSING THE COMPLICATION WAS THE MEDTRONIC COVIDIEN SIGNIA STAPLER. THE PATIENT'S HOSPITALIZATION WAS PROLONGED AS A RESULT OF THE COMPLICATION." }, { "mdr_text_key": "306640306", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT MIDDLE LOBE PULMONARY LOBECTOMY PROCEDURE, THE PATIENT, WHO WAS PART OF A COMPLETED PILOT STUDY OF SINGLE PORT ROBOTIC SURGERY FOR ANATOMICAL LUNG RESECTION, EXPERIENCED HEMOPTYSIS. AN X-RAY DONE ON THE PATIENT SHOWED PLEURAL EFFUSION. THE PATIENT UNDERWENT A RE-OPERATION. INTRA-OPERATIVELY, SEVERE PULMONARY CONGESTION WAS FOUND DUE TO A \"MAL-RESECTION\" OF PREVIOUS S2 SEGMENTAL VEIN DRAINAGE. THE PLEURAL EFFUSION AND BLOOD CLOT WERE RETRIEVED BY SINGLE PORT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) TECHNIQUE. THE SURGEON THEN DISSECTED THE POSTERIOR PART OF THE LUNG FISSURE AND EXPLORED THE A2 ( POSTERIOR ASCENDING BRANCH OF PULMONARY ARTERY). ECCHYMOSIS OF A2 WAS FOUND. THE SURGEON COMPLETED THE ANTERIOR HORIZONTAL FISSURE USING THE HARMONIC SCALPEL TO LOOSEN THE HILAR AREA AND USED TWO HEM-O-LOCKS CLIPS AS WELL AS THE HARMONIC SCALPEL TO RESECT THE A2 BRANCH. THEN THE RIGHT UPPER LOBE CONGESTION CONDITION IMPROVED. THE SURGEON BELIEVES THAT THE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO THE UNCOMMON ANATOMY CAUSING BLOOD FROM UPPER LOBE TO FLOW BACK TO MID-LOBE, RESULTING IN THE BLOOD CLOT. THE SUSPECTED DEVICE INVOLVED IN CAUSING THE COMPLICATION WAS THE MEDTRONIC COVIDIEN SIGNIA STAPLER. THE PATIENTS HOSPITALIZATION WAS PROLONGED AS A RESULT OF THE COMPLICATION. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }