{ "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": "2955842-2021-11624", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20211129", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211102", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20211129", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210824", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1779344", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211129", "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": "L90210824 0191", "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)230831(10)L90210824", "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": "OH", "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": "20211129", "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", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20211102", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12887681", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211102", "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": "281579006", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ISI REQUESTED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT TO BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION, HOWEVER IT HAS NOT YET BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THE LOGS WERE REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS ENGINEER (FAE) AND THE FOLLOWING INFORMATION WAS OBTAINED: THE SYNCHROSEAL WAS USED FOR APPROXIMATELY 10 MINUTES. THE ONLY MESSAGES RECORDED WERE 3 ¿HIGH INITIAL STARTING IMPEDANCE¿ MESSAGES. WHEN RECORDED, THIS INDICATES THE IMPEDANCE OF THE TISSUE BETWEEN THE JAWS WAS HIGHER THAN EXPECTED. THIS IS MOST LIKELY DUE TO TISSUE THICKNESS, TISSUE TYPE, TISSUE DRYNESS OR AMOUNT OF FLUID PRESENT. THE INSTRUMENT APPEARS TO HAVE BEEN USED SUCCESSFULLY FOLLOWING EACH OF THESE MESSAGES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A PARAOESOPHAGEAL HERNIA REPAIR, THE SYNCHROSEAL WHICH WAS USED TO SEAL THE SHORT GASTRIC VESSELS AND OMENTUM AT THE GREATER CURVATURE OF THE STOMACH DID NOT SEAL SUFFICIENTLY. AS A RESULT, THE VESSELS WERE OOZING/ BLEEDING WHEN CUT. THE SURGEON USED A VESSEL SEALER EXTEND TO STOP THE BLEEDING. AT THIS TIME, THE CAUSE OF THE ALLEGED EVENT IS UNKNOWN." }, { "mdr_text_key": "281579007", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED HIATAL-HERNIA PERIESOPHAGEAL SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT DID NOT WORK TO STOP THE BLEEDING. IT IS UNCLEAR WHAT SURGICAL TASK THE SURGEON WAS ATTEMPTING TO PERFORM WHEN THE REPORTED EVENT OCCURRED. THE SURGEON HAD TO SWITCH TO A VESSEL SEALER EXTEND INSTRUMENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI EXECUTIVE SALES REPRESENTATIVE (ESR) WHO WAS PRESENT FOR THE PROCEDURE AND OBTAINED ADDITIONAL INFORMATION ON 16-NOV-2021. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SYNCHROSEAL INSTRUMENT WAS NOT SEALING THE SHORT GASTRIC VESSELS ALONG THE GREATER CURVATURE OF THE STOMACH IN THE SYNCH AND SEAL MODES. THE CUTTING FUNCTION WAS WORKING IN THE SYNCH MODE BUT NOT THE SEALING FUNCTION ALTHOUGH THE GENERATOR GAVE THE APPROPRIATE TONES. AS A RESULT, THE VESSELS WERE OOZING/ BLEEDING. THE ESTIMATED BLOOD LOSS WAS LESS THAN 750 ML. THE SURGEON THEN USED A VESSEL SEALER EXTEND INSTRUMENT TO OBTAIN CONTROL AND STOP THE BLEEDING FROM THE SHORT GASTRIC VESSELS. THERE WERE NO ERRORS THAT OCCURRED AT THE TIME OF THE INCIDENT. THERE WAS NO EXCESSIVE TENSION OF TISSUE, THE VESSEL SIZE WAS LESS THAN 5 MM, THERE WAS NO VESSEL CALCIFICATION, AND NO PREVIOUS EXPOSURE OF THE VESSEL TO CHEMOTHERAPY AND RADIATION. THE JAWS OF THE INSTRUMENT DID NOT COME INTO CONTACT WITH ANY CLIP/SUTURE/STAPLE OR METAL OBJECTS AND WERE NOT IMMERSED IN LIQUID DURING THE SEALING OF VESSELS. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE INSTRUMENT IS AVAILABLE FOR EVALUATION." } ], "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": "" } ] }