{ "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": "2955842-2024-11236", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240222", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240125", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "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": "20240222", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "67073", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240222", "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": "480440-06", "catalog_number": "480440", "lot_number": "L12230601", "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)250531(10)L12230601", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Deliver Energy", "Failure to Deliver Energy" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250827", "health_professional": "Y", "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": "20240222", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20240126", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18760152", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20240126", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "336013993", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS (FA) COULD NOT BE PERFORMED. ADVANCE ENERGY LOG REVIEW SHOWED THAT THE SYNCHROSEAL INSTRUMENT (LOT #: L12230601-0094) HAD ONE COAG EVENT AND SIX SEAL EVENTS WITH NO ERRORS. ADDITIONALLY, THERE WERE 41 TRANSECT EVENTS, WITH TWO ¿BLANK¿ ERRORS. THE INSTRUMENT WAS USED FOR ABOUT ONE HOUR AND THREE MINUTES. THE LOGS SHOW SOME ERRORS THAT ARE NOT RELATED TO THE COMPLAINT. IT IS LIKELY THAT DUE TO A POSSIBLE CONTACT OF THE INSTRUMENT JAWS WITH A METALLIC OBJECT, THE SEALING MIGHT HAVE BEEN COMPROMISED. A REVIEW OF A VIDEO OF THE EVENT SHOWED THE SYNCHROSEAL INSTRUMENT WAS INSERTED AT AROUND 23:11, AT 23:27 THE INSTRUMENT GRASPS THE VESSEL; THE INSTRUMENT ALSO APPEARS TO HAVE GRASPED A LITTLE BIT OF A STAPLE. AT 23:30 SYNC MODE IS ACTIVATED AND AT 23:41 THERE IS A ERROR MESSAGE OF \"EXCESS FLUID OR METAL OBJECT, WHICH MAY COMPROMISE THE SEAL.\" SYNC IS CONTINUED TO BE ACTIVATED WITHOUT ADJUSTING THE GRASP AND THE ERROR MESSAGE APPEARS AGAIN AT 23:52. AT 23:53 THE JAWS WERE OPENED AND THERE IS A BLEEDING EVENT. THE USER MANUAL GENERALLY WARNS AGAINST GRASPING/TOUCHING CLIPS/STAPLES WHILE APPLYING ENERGY." }, { "mdr_text_key": "336014017", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, THERE WAS AN INSUFFICIENT SEAL AFTER USING THE SYNCHROSEAL INSTRUMENT AND BLEEDING OCCURRED. PRIOR TO SEALING THE ASCENDING BRANCH OF THE INTERLOBAR ARTERY TO THE UPPER LOBE (A2), THE \"CENTER SIDE\" OF THE VESSEL WAS CLIPPED. THEN USING THE SYNCHROSEAL INSTRUMENT TO LIGATE THE A2, A SEAL FUNCTION WAS PERFORMED, FOLLOWED BY A CUT FUNCTION. BLEEDING WAS THEN OBSERVED FROM THE PERIPHERY. THE SURGEON REPORTED WHEN USING THE SYNCHROSEAL FOR THE LIGATION, IT OCCURRED CLOSE TO A STAPLE LINE; AND THAT IT'S POSSIBLE THE INSUFFICIENT SEAL WAS CAUSED BY A METAL-LIKE OBJECT BETWEEN THE INSTRUMENT JAWS. THE BLEEDING WAS REPORTED AS A SMALL AMOUNT ON THE SPECIMEN SIDE, AND WAS RESOLVED BY SUTURE LIGATING THE VESSEL. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS STILL IN THE HOSPITAL, BUT THERE HAVE BEEN NO POST-OPERATIVE COMPLICATIONS." } ], "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": "" } ] }