{ "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": "2955842-2022-12702", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220630", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220701", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211028", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1472646", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220630", "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": "L91211101", "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)231031(10)L91211101", "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": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20220630", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "49 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels", "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20220601", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14881842", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220601", "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": "295125470", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS REMOVAL PROCEDURE, THE CASE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE PEELED THE TUMOR FROM THE HEART USING THE CADIERE FORCEPS AND THE SYNCHROSEAL INSTRUMENTS. AT THAT TIME, THE SURGEON INDICATED THAT HE \"PUT A HOLE IN THE INNOMINATE VEIN\" WITH THE SYNCHROSEAL INSTRUMENT. AS A RESULT, THE PATIENT EXPERIENCED BLEEDING. THE SURGEON IMMEDIATELY APPLIED PRESSURE WITH GAUZE USING THE SYNCHROSEAL INSTRUMENT (CLOSED JAWS) ON ARM 1. THE SURGEON CONFIRMED THE SYNCHROSEAL WAS NOT USED FOR SEALING AT THAT TIME. WHILE THE OR STAFF AND A RESIDENT WERE PLANNING THE CONVERSION, THE SYSTEM GENERATED A RECOVERABLE FAULT. AS A RESULT, THE SURGEON WAS UNABLE TO APPLY PRESSURE MOMENTARILY ON THE INJURED VESSEL UNTIL THE FAULT WAS RECOVERED. THE ASSISTANT RECOVERED THE FAULT WITHIN APPROXIMATELY 14-15 SECONDS, AND THE SURGEON WAS THEN ABLE TO CONTINUALLY APPLY PRESSURE ON THE INNOMINATE VEIN. HOWEVER, THE PATIENT BLED A LITTLE MORE DUE TO THE ADDITIONAL TIME IT TOOK TO RECOVER THE FAULT AND THEN THE PROCESS OF CONVERSION CONTINUED. ONCE THE PROCEDURE WAS CONVERTED TO OPEN, THE SURGEON REPAIRED THE INJURED VESSEL WITH SUTURES. THE SURGEON INDICATED THAT NO SYSTEM MALFUNCTION CONTRIBUTED TO THE BLEEDING OR THE CONVERSION. HOWEVER, THE SURGEON MENTIONED THAT THIS WAS THE FIRST MEDIASTINAL MASS PROCEDURE HE HAD EVER CONVERTED. IT WAS CONFIRMED THE SYSTEM HAS BEEN USED IN SUBSEQUENT PROCEDURES. THE PATIENT DID EXPERIENCE AN EXTENDED HOSPITAL STAY SECONDARY TO THE CONVERSION. THE SURGEON STATED THE ESTIMATED BLOOD LOSS WAS ABOUT 1 LITER. THE PATIENT HAD A COUPLE OF UNITS OF BLOOD TRANSFUSION. THE SURGEON STATED THE STANDARD PROTOCOL FOR MEDIASTINAL MASS REMOVAL PROCEDURES IS FOR THE PATIENTS TO BE DISCHARGED ON POSTOPERATIVE DAY #1; HOWEVER, DUE TO THE VESSEL INJURY THAT LED TO THE CONVERSION, THIS PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY #3. THE PATIENT IS REPORTED TO BE RECOVERING WELL. THERE IS NO VIDEO RECORDING OF THE PROCEDURE FOR ISI TO REVIEW." }, { "mdr_text_key": "295125471", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. HOWEVER, THE SURGEON INDICATED THAT INNOMINATE VEIN BEGAN TO BLEED WHEN HE PEELED THE TUMOR FROM THE HEART USING THE CADIERE FORCEPS AND THE SYNCHROSEAL INSTRUMENTS. FURTHERMORE, THE SURGEON INDICATED THAT NO SYSTEM MALFUNCTION CONTRIBUTED TO THE BLEEDING OR THE REASON FOR THE CONVERSION TO OPEN SURGERY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS GIVEN ACCESS TO THE SURGEON SIDECONSOLE (SSC). THE FSE FOUND NO PHYSICAL DAMAGE AND WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THE SITE CONFIRMED THAT THE CONSOLE WAS INSPECTED BY A FSE AND THE CONSOLE HAD BEEN USED IN SUBSEQUENT PROCEDURES. THE SITE CONFIRMED THAT THE INSTRUMENTS USED WILL NOT BE RETURNED TO ISI FOR EVALUATION, AS THERE WAS NO ALLEGATION THAT THE INSTRUMENTS CAUSED THE INTRA-OPERATIVE COMPLICATION. THE SYNCHROSEAL HAS BEEN DISCARDED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MEDIASTINAL MASS REMOVAL PROCEDURE, THE INNOMINATE VEIN WAS INJURED WHEN HE SURGEON PEELED THE TUMOR FROM THE HEART. AS A RESULT OF THE VESSEL INJURY, BLEEDING OCCURRED. AS THE SURGEON WAS APPLYING PRESSURE TO CONTROL THE BLEEDING, THE PROCEDURE WAS BEING CONVERTED TO AN OPEN PROCEDURE. AT THAT TIME, THE SYSTEM GENERATED A RECOVERABLE FAULT AT THAT TIME. THE PATIENT BLED A LITTLE MORE WHILE THE FAULT WAS BEING RECOVERED. THE PROCEDURE WAS THEN CONVERTED TO AN OPEN SURGICAL PROCEDURE, AND THE BLEEDING VEIN WAS REPAIRED. IT WAS CONFIRMED THAT THE RECOVERABLE ERROR DID NOT LEAD TO THE BLEEDING OR THE CONVERSION OF THE PROCEDURE. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "" } ] }