{ "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": "2955842-2021-11495", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211112", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211013", "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": "20211113", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210722", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1700953", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211112", "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": "L90210726 0118", "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)230731(10)L90210726", "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": "WI", "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": "20211112", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "225 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20211014", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12807993", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211014", "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": "280821079", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. ISI REQUESTED FOR RETURN OF THE SYNCHROSEAL INSTRUMENT USED TO SEAL THE SHORT GASTRIC ARTERY, PART NUMBER: 480440-05, LN: L90210726-0118 FOR FAILURE ANALYSIS INVESTIGATION; HOWEVER, THE SURGEON CONFIRMED THAT THE INSTRUMENT WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. NO IMAGE OR VIDEO RECORDING WAS PROVIDED TO ISI FOR REVIEW. A LOG REVIEW FOR THE SYNCHROSEAL INSTRUMENT USED IN THIS EVENT HAS BEEN PERFORMED: THE SYNCHROSEAL WAS USED FOR 49 MINUTES. THERE WERE FIVE HIGH INITIAL STARTING IMPEDANCE MESSAGES RECORDED, WHICH INDICATE THE IMPEDANCE OF THE TISSUE BETWEEN THE JAWS WAS HIGHER THAN EXPECTED- MOST OFTEN DUE TO TISSUE TYPE, THICKNESS, OR DRYNESS. THE FINAL ACTIVATION OF THE INSTRUMENT'S USE RECORDED A TRANSECT TIMEOUT, INDICATING THE TRANSECT SEQUENCE WAS ACTIVATED FOR LONGER THAN THE ALLOWABLE LIMIT (10 SECONDS). POTENTIALLY, THIS CAN BE CAUSED BY A DIRECT SHORT OF THE ELECTRODES, SUCH AS APPLYING ENERGY OVER A METAL CLIP OR STAPLE. AFTER THE TRANSECT TIMEOUT, THERE ARE NO OTHER INSTRUMENT ACTIVATIONS RECORDED. NO ERRORS WERE RECORDED THAT WOULD SUGGEST A FAILURE OF THE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT A FEW HOURS AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND HE EXHIBITED SIGNS OF INTERNAL BLEEDING. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, AND APPROXIMATELY 4.5 LITERS OF BLOOD WAS IDENTIFIED IN HIS STOMACH. THE SURGEON REMOVED THE CLOTS AND DRAINED THE BLOOD. AS A PRECAUTION, SHE PLACED CLIPS ON THE STAPLE LINES, APPLIED SURGICEL ON THE SEAL OF THE SHORT GASTRIC ARTERY, AND SEALED THE OMENTUM WITH A HARMONIC SCALPEL INSTRUMENT. THE SURGEON SPECULATED THAT THE CAUSE OF THE BLEEDING COULD HAVE BEEN DUE TO A SPASM OF THE SHORT GASTRIC ARTERY RIGHT AFTER THE PROCEDURE, WHICH COULD HAVE RESOLVED ON ITS OWN. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF AN ISI DEVICE AND NO ISSUES WITH SEALING. THE CAUSE OF THE POST-OPERATIVE BLEEDING IS UNKNOWN." }, { "mdr_text_key": "280821080", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED THAT A FEW HOURS AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXHIBITED SIGNS OF A LEAK. THE PATIENT HAD 4.5 L OF BLOOD IN HIS STOMACH THAT WAS DRAINED IN A SUBSEQUENT PROCEDURE. ON 15-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS AN AFRICAN AMERICAN MALE, WEIGHING (B)(6) LBS, WITH A MEDICAL HISTORY OF OBESITY, SLEEP APNEA, AND HYPERTENSION. IT WAS REPORTED THAT A FEW HOURS AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND HE EXHIBITED SIGNS OF INTERNAL BLEEDING. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, AND APPROXIMATELY 4.5 LITERS OF BLOOD WAS IDENTIFIED IN HIS STOMACH. THE SURGEON REMOVED THE CLOTS AND DRAINED THE BLOOD. AS A PRECAUTION, SHE PLACED CLIPS ON THE STAPLE LINES, APPLIED SURGICEL ON THE SEAL OF THE SHORT GASTRIC ARTERY, AND SEALED THE OMENTUM WITH A HARMONIC SCALPEL INSTRUMENT. THE SURGEON COULD NOT CONFIRM THE SOURCE OF THE BLEEDING; HOWEVER, SHE BELIEVES IT COULD HAVE BEEN DUE TO SPASM OF THE SHORT GASTRIC ARTERY RIGHT AFTER THE PROCEDURE, WHICH COULD HAVE RESOLVED ON ITS OWN. SHE CONFIRMED THE STAPLE LINES WERE INTACT, THE LIVER AND SPLEEN WERE FINE. THE SYNCHROSEAL INSTRUMENT WAS USED ON THE SHORT GASTRIC ARTERY, AND THERE WAS NO ISSUE WITH SEALING. THE SURGEON CONFIRMED THERE WAS NO INTRA-OPERATIVE BLEEDING OR ANY INTRAOPERATIVE COMPLICATION. THE PATIENT HAD LOST ABOUT 4.5 LITERS OF BLOOD, AND FOUR UNITS OF BLOOD WERE TRANSFUSED. THE PATIENT WAS ON A VENTILATOR FOR AN ADDITIONAL DAY, SECONDARY TO THE BLEEDING, AS HE WAS RE-INTUBATED FOR THE DIAGNOSTIC PROCEDURE. AS OF TODAY, THE PATIENT HAS BEEN TRANSFERRED TO AN UNSPECIFIED ROOM AND RECOVERING WELL. THE SURGEON CONFIRMED THE FOLLOWING: THE PATIENT DID NOT HAVE ANY PRE-EXISTING COAGULOPATHY CONDITION. THE PATIENT WAS NOT ON BLOOD THINNER TREATMENT. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE INITIAL SLEEVE GASTRECTOMY. THE SYNCHROSEAL INSTRUMENT USED ON THE SHORT GASTRIC ARTERY WAS DISCARDED, AS THERE WAS NO MALFUNCTION OF THE DEVICE AND NO ISSUES WITH SEALING. HENCE, THE INSTRUMENT WILL NOT BE RETURNED TO ISI 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": "" } ] }