{ "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": "2955842-2022-13523", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220818", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220719", "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": "BE", "manufacturer_contact_area_code": "408", "date_added": "20220819", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220413", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2070471", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220818", "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": "L90220418 0241", "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)240430(10)L90220418", "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": "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": "20220818", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "66 YR", "patient_sex": "Male", "patient_weight": "83 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15255859", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20220720", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification", "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": "298199420", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, BLEEDING OCCURRED FROM ONE OF THE TWO BRANCHES OF THE AORTIC ARCH LEADING TO THE ESOPHAGUS. THE ISSUE OCCURRED 15 MINUTES AFTER SEALING AND TRANSECTING THE SIDE BRANCH WITH A SYNCHROSEAL INSTRUMENT. THE SIDE BRANCH WAS PROPERLY FREED FORM SURROUNDING TISSUE AND THEN SEALED WHILE DEEP IN THE JAWS OF THE SYNCHROSEAL. THE SURGEON PERFORMED A FULL CYCLE OF SEALING, OBSERVED TISSUE EFFECT DURING THE SEALING PROCESS, AND THEN TRANSECTED. THE SURGEON BELIEVES THE SEAL COULD NOT HANDLE THE PRESSURE FROM THE AORTIC BRANCH AND BEGAN BLEEDING 15 MINUTES LATER. THE SURGEON WAS ABLE TO TAMPONADE THE BLEEDING WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) BY USING COMPRESSION. USM2, 3, AND 4 WERE THEN REMOVED. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO A THORACOTOMY TO CONTROL THE HEMORRHAGE. THE SURGEON PERFORMED SUTURE LIGATION OF THE BLEEDING SITE ON THE AORTA AND THE PATIENT WAS TRANSFUSED 2 UNITS OF PACKED CELLS. BLOOD LOSS WAS ESTIMATED TO BE BETWEEN 500 AND 600ML. THE SURGEON INDICATED THAT THE PATIENT WAS DOING FINE AND RECOVERING POST-OPERATIVELY. HOWEVER, THE SURGEON NOTED THAT THE PATIENT MAY HAVE EXPERIENCED SUSPECTED PNEUMONIA AND RECEIVED IV ANTIBIOTICS. THE SURGEON INDICATED THAT THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES OR DAMAGE WAS IDENTIFIED AT THE TIME. ALSO, PER THE SURGEON, THE SYNCHROSEAL INSTRUMENT WAS USED FOR 4-5 HOURS BEFORE THE EVENT OCCURRED AND FUNCTIONED NORMALLY. THE SIDE BRANCH WAS APPROXIMATELY 5MM OR LESS IN DIAMETER AND DID NOT HAVE EVIDENCE OF VESSEL CALCIFICATION. THE VESSEL WAS NOT UNDER TENSION DURING THE SEALING. FURTHERMORE, THE JAWS OF THE SYNCHROSEAL INSTRUMENT DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER OBSTRUCTION WHEN THE EVENT OCCURRED. THE INSTRUMENT¿S JAWS WERE ALSO NOT IMMERSED IN LIQUID OR CONTAMINATED WITH CARBONIZED TISSUE (BIO-DEBRISS) PRIOR TO OR DURING THE SEALING CYCLE. BEFORE THE SURGERY, THE SURGEON INDICATED THAT THE TISSUE MAY HAVE BEEN WITHIN THE IRRADIATION FIELD OF THE ESOPHAGUS." }, { "mdr_text_key": "298199421", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AN ADVANCED INSTRUMENT LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, AFTER REVIEWING THE LOGS, IT SEEMS AS THOUGH THERE WAS ONLY ONE INSTANCE WHERE THERE WAS TOO MUCH TISSUE IN THE JAWS CAUSING HIGH INITIAL STARTING IMPEDANCE; HOWEVER, AFTER THAT, THE USER WAS ABLE TO UTILIZE THE SEALING FEATURE MULTIPLE TIMES WITHOUT ERROR. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, BLEEDING OCCURRED FROM ONE OF THE TWO BRANCHES OF THE AORTIC ARCH LEADING TO THE ESOPHAGUS. THE ISSUE OCCURRED 15 MINUTES AFTER SEALING AND TRANSECTING THE SIDE BRANCH WITH A SYNCHROSEAL INSTRUMENT. THE SURGEON BELIEVES THE SEAL COULD NOT HANDLE THE PRESSURE FROM THE AORTIC BRANCH AND BEGAN BLEEDING. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE SURGEON SUTURE LIGATED THE BLEEDING SITE AND THE PATIENT WAS ADMINISTERED A BLOOD TRANSFUSION. 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": "" } ] }