{ "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": "2955842-2022-12575", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220629", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20200513", "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": "20220630", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20191017", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1090031", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220629", "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": "T90191017 0059", "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)211031(10)T90191017", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20220629", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hematoma" ] } ], "distributor_city": "", "date_report": "20200904", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14861164", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200904", "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": "295125310", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE AVAILABLE INFORMATION, IT IS BELIEVED THAT THE CAUSE OF THE REPORTED HEMATOMA AND NEED FOR AN ADDITIONAL SURGERY WAS DUE TO THE PATIENT BEING PUTTING ON AN ANTICOAGULANT TOO EARLY. IN THIS CASE, THE SLEEVE GASTRECTOMY PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED WITH NO ISSUES REPORTED. THE HEMATOMA WAS DISCOVERED POST PROCEDURALLY AND THE PATIENT THEN UNDERWENT A SECOND PROCEDURE TO ADDRESS IT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE LOG REVIEW SUPPORTS THE SURGEON CLAIM THAT THERE WAS NO PRODUCT ISSUE DURING THE CASE. NO IMAGE OR VIDEO WAS PROVIDED FOR ISI TO REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY DEVELOPED A HEMATOMA NEAR THE AREA OF DISSECTION AND UNDERWENT A SECOND PROCEDURE TO ADDRESS THE HEMATOMA. AS REPORTED, THE SURGEON BELIEVED THAT THE CAUSE OF THE HEMATOMA WAS DUE TO THE PATIENT BEING PUTTING ON AN ANTICOAGULANT TOO EARLY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED." }, { "mdr_text_key": "295125311", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BARIATRIC REVISION SURGICAL PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA NEAR THE AREA OF DISSECTION WITH A SYNCHROSEAL INSTRUMENT. INITIAL INFORMATION RECEIVED FROM THE REPORTER INDICATED THAT HE BELIEVED THIS WAS CAUSED BY THE SYNCHRO SEAL INSTRUMENT THAT WAS USED DURING A BARIATRIC ROBOTIC PROCEDURE. THE PATIENT REPORTEDLY HAD A SECOND (UNSPECIFIED) PROCEDURE TO ADDRESS THE HEMATOMA. IT WAS NOTED THAT THE INSTRUMENT WAS DISCARDED AS NO ISSUE WAS SUSPECTED FOLLOWING INITIAL PROCEDURE COMPLETION. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER UNDERGOING A SLEEVE GASTRECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED WITH NO ISSUE REPORTED. HOWEVER, POST-OPERATIVELY THE PATIENT HAD NOT BEEN ¿FEELING WELL¿ AND CALLED THE SURGEON TO REPORT IT. THE SURGEON RECOMMENDED THAT THE PATIENT COME INTO THE HOSPITAL. HOWEVER, THE PATIENT DECIDED TO GO TO ANOTHER HOSPITAL TO SEEK TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DIAGNOSTIC TEST CONDUCTED, WHICH INDICATED A POSSIBLE HEMATOMA. IT IS BELIEVED THAT THE PATIENT UNDERWENT A SECOND PROCEDURE TO ADDRESS THE HEMATOMA. ON (B)(6)2020, FOLLOW-UP WAS CONDUCTED WITH THE SURGEON. THE SURGEON INDICATED THAT HE CLEARLY REMEMBERED THE CASE AND STATED THAT THERE WAS NO PROBLEM WITH THE USE OF SYNCHROSEAL INSTRUMENT DURING THE PROCEDURE, AND THERE WAS NO SEALING ISSUE NOTED. THE SURGEON CONFIRMED THAT THE ISI DEVICE WORKED WELL, AND THERE WAS NO INTRA-OPERATIVE COMPLICATION DURING THE PROCEDURE. THE SURGEON FURTHER INDICATED THAT THE PATIENT HAS HAD A HISTORY OF PULMONARY EMBOLISM, AND THAT HE HAD STARTED THE PATIENT ON ANTICOAGULANTS TOO EARLY, WHICH RESULTED IN THE HEMATOMA¿S OCCURRENCE. AS A RESULT, THE PATIENT UNDERWENT A SECOND PROCEDURE AT A DIFFERENT HOSPITAL TO ADDRESS THE HEMATOMA. THE SURGEON REITERATED THAT THE ISSUE WAS SECONDARY TO PUTTING THE PATIENT ON AN ANTICOAGULANT TOO EARLY, AND NOT RELATED TO AN ISI PRODUCT. THE SURGEON ALSO STATED THAT HE \"WOULD HAVE INFORMED ISI IF THERE WAS A SLIGHT HINT THAT THE ISSUE WAS RELATED TO AN ISI PRODUCT, WHICH WAS NOT SO IN THIS CASE.¿" } ], "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": "" } ] }