{ "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": "2955842-2022-10217", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220210", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220111", "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", "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": "20220210", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211111", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "258880", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220210", "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": "L91211114 0159", "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)231130(10)L91211114", "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": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20220210", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES," ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Hematoma", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220113", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13503775", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220113", "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": "289954508", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND THE PATIENT POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. THE SYNCHROSEAL INSTRUMENT IS UNAVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM LOGS WERE REVIEWED AND THE FOLLOWING INFORMATION WAS OBTAINED: NO ERRORS WERE FOUND IN THE E-100 GENERATOR LOGS THAT WOULD SUGGEST AN INSTRUMENT FAILURE. THERE WERE TWO ¿HIGH INITIAL STARTING IMPEDANCE¿ MESSAGES RECORDED, BUT THESE MESSAGES ARE MORE REPRESENTATIVE OF CLINICAL CONDITIONS SUCH AS THE AMOUNT OF TISSUE IN THE JAWS, TISSUE TYPE, TISSUE DRYNESS, ETC. WHEN THIS EVENT TRIGGERS, ENERGY DELIVERY STOPS AFTER HALF A SECOND, AND THE MESSAGE DISPLAYS ON THE USER INTERFACE AS ¿ENSURE THE APPROPRIATE AMOUNT OF TISSUE IN JAWS. INCOMPLETE SEAL CYCLE.¿ THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. THE SURGEON ALLEGED THAT THE SYNCHROSEAL INSTRUMENT WAS A CONTRIBUTING FACTOR TO THE POST-OPERATIVE COMPLICATION. ON POST-OPERATIVE DAY #1, THE PATIENT BECAME HYPOTENSIVE, FELL, AND BROKE HER VERTEBRAE. AS A RESULT OF THE BROKEN VERTEBRAE, SHE UNDERWENT A SECOND PROCEDURE AND WAS IN THE ICU. THE CAUSE OF THE POST-OPERATIVE BLEEDING IS UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." }, { "mdr_text_key": "289954509", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ON POST-OPERATIVE DAY #1, THE PATIENT BECAME HYPOTENSIVE AND FELL. AS A RESULT, THE PATIENT ALLEGEDLY BROKE HER VERTEBRAE. THE PATIENT WAS TAKEN BY AMBULANCE TO A NEARBY HOSPITAL (DIFFERENT FROM THE HOSPITAL WHERE THE DA VINCI-ASSISTED SLEEVE GASTRECTOMY WAS PERFORMED). THE PATIENT WAS ADMITTED IN THE ICU. A CT SCAN REVEALED A HEMATOMA. AN ARTERIOGRAM CONFIRMED THERE WAS NO ACTIVE BLEEDING. THE PATIENT UNDERWENT A SECOND PROCEDURE FOR THE BROKEN VERTEBRAE. THE SURGEON REPORTED THAT HE BELIEVES THE POSTOPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO AN ALLEGED INSUFFICIENT SEAL INVOLVING THE USE OF A SYNCHROSEAL INSTRUMENT. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING." } ], "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": "" } ] }