{ "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": "2955842-2021-11521", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20211116", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211018", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20211116", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201029", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1719887", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211116", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-05", "catalog_number": "480440", "lot_number": "L90201018", "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": "10886874117306", "udi_public": "(01)10886874117306(17)221031(10)L90201018", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20211116", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20211018", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12821924", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211018", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "282396162", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN .THE SITE CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS DISCARDED, HENCE THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. A REVIEW OF THE SYSTEM LOGS WAS COMPLETED. ALL OF THE ERRORS IN THE LOGS FOR THAT PROCEDURE ARE CLASS 0 (SYSTEM SERVICE ADVISORY (NO FAULT REACTION)) AND CLASS 8 (ENGINEERING EVENT INFORMATIONAL (NO FAULT REACTION)). NONE OF THESE WOULD SUGGEST A PRODUCT ISSUE. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS CONSIDERED A REPORTABLE ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, DURING THE TREATMENT OF THE HILAR REGION OF THE LUNG WITH A SYNCHROSEAL INSTRUMENT, THE PATIENT EXPERIENCED BLEEDING. THE SURGEON COULD NOT CONTROL THE BLEEDING; AS A RESULT, THE SURGEON DECIDED TO CONVERT TO OPEN CHEST SURGERY. THE CAUSE OF THE INJURY TO THE BLOOD VESSEL MAY MECHANICAL TRAUMA DUE TO THE \"PEELING\" TECHNIQUE DUE TO POOR VISUALIZATION RESULTING FROM THE SURGICAL APPROACH. HOWEVER, IT IS UNCLEAR IF THERE WAS AN ISSUE WITH THE SYNCHROSEAL. ." }, { "mdr_text_key": "282396163", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, DURING \"VASCULARIZATION\" OF THE HILAR REGION OF THE LUNG, THE PATIENT EXPERIENCED BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT DISCLOSED. THE SURGEON COULD NOT CONTROL THE BLEEDING; MEDIUM-LARGE CLIPS WERE USED TO IN AN ATTEMPT TO CONTROL THE BLEED WITHOUT SUCCESS. AS A RESULT, THE SURGEON DECIDED TO CONVERT TO OPEN CHEST SURGERY. ON 25-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING DURING HILAR VASCULAR TREATMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON INDICATED THAT THE CAUSE OF THE BLEED MIGHT HAVE BEEN RELATED TO \"TENSION\" OR DAMAGE TO AN UNSPECIFIED VESSEL WHEN \"PEELING\" AND \"NOT CUTTING\" WITH THE SYNCHROSEAL INSTRUMENT. IT IS UNCLEAR WHAT THE SURGEON MEANT BY \"PEELING.\" THE SURGEON TRIED TO STOP THE BLEEDING WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT AND SUCTIONING. THE SURGEON APPLIED JUST ONE CLIP BUT WAS UNABLE TO PLACE A SECOND CLIP FOR AN UNKNOWN REASON. THE SURGEON COULD NOT CONTROL THE BLEEDING. DUE TO THE EXCESSIVE AMOUNT OF BLEEDING, THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN THORACOTOMY. IT WAS CONFIRMED THAT THE PATIENT¿S ANATOMY OR THE SYSTEM¿S ARM MOVEMENT DID NOT CONTRIBUTE TO THE BLEEDING. THE CAUSE OF THE BLEEDING IS NOT CLEAR; HOWEVER, THE SURGEON SPECULATED IT TO BE \"DUE TO THE POOR SURGICAL FIELD AND LACK OF WORKSPACE.\" IT WAS FURTHER EXPLAINED THAT \"SINCE THE PROCEDURE WAS PERFORMED USING THE 3-ARM TECHNIQUE, WHICH RELIED ON AN ASSISTANT TO PERFORM THE DEPLOYMENT, A PNEUMOTHORAX WAS NOT POSSIBLE, RESULTING IN THE CONDITION.\" ADDITIONALLY, THE SURGEON INDICATED, \"ASSISTANT CONDUCT MIGHT NOT BE ENOUGH,\" IN REFERENCE TO EXPLAINING THE \"DEPLOYMENT.\" IT WAS ALSO NOTED THAT THE PATIENT'S ANATOMY HAD NOTHING TO DO WITH THE SURGICAL FIELD. THE FOLLOWING INFORMATION WAS ASKED BUT THE DETAILS ARE UNKNOWN: THE SIZE OF THE VESSEL. THE ESTIMATED BLOOD LOSS. IF ANY BLOOD TRANSFUSION WAS RENDERED. HOW THE BLEEDING WAS CONTROLLED AFTER THE CONVERSION. THE PATIENT'S DEMOGRAPHIC DETAILS." } ], "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": "" } ] }