{ "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": "2955842-2021-11504", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211115", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20211019", "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": "20211115", "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": "1714044", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211115", "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": "L90210727", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211109", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)230731(10)L90210727", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/15/2021", "mfr_report_type": "Follow-Up", "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": "20211115", "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": "20211021", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12809558", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211021", "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": "285247806", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT. HOWEVER, THE FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED UPON THE COMPLETION OF FAILURE ANALYSIS AND IF ADDITIONAL INFORMATION IS OBTAINED. A SITE HISTORY COMPLAINT REVIEW WAS CONDUCTED FOR THE PROCEDURE DATE OF (B)(6) 2021 AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. 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. WHILE NOT ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. AN ISI FAILURE ANALYSIS ENGINEER REVIEWED THE INSTRUMENT LOGS FOR THE SYNCHROSEAL USED DURING THIS PROCEDURE AND THE FOLLOWING INFORMATION WAS PROVIDED: THE SYNCHROSEAL INSTRUMENT WAS USED FOR 2 MINUTES WITH 2 ACTIVATIONS RECORDED BY THE E-100 GENERATOR. THE FIRST ACTIVATION TRIGGERED A TRANSECT TIMEOUT MESSAGE, INDICATING THAT ENERGY WAS APPLIED FOR THE MAXIMUM ALLOWED TIME. THE TRANSECT TIMEOUT MESSAGE POSSIBLY SUGGESTS A DIRECT SHORT OF THE JAWS. THE SECOND ACTIVATION WAS A SEAL EVENT WITH NO ASSOCIATED ERRORS OR MESSAGES. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI ASSISTED PULMONARY LOBECTOMY, IT WAS ALLEGED THAT A SYNCHROSEAL INSTRUMENT DID NOT SUFFICIENTLY COMPLETE A SEAL ON A VESSEL WHICH RESULTED WITH AN UNSPECIFIED AMOUNT OF BLEEDING. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED, IF ANY, TO RESOLVE THE VESSEL BLEEDING. AT THIS TIME, THE ROOT CAUSE OF THE ALLEGED EVENT IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE 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": "285247807", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS INITIALLY REPORTED BY THE SITE¿S ROBOTIC COORDINATOR TO INTUITIVE SURGICAL INC, (ISI) CUSTOMER SERVICE, THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE SYNCHROSEAL INSTRUMENT ALLEGEDLY MISFIRED AND DID NOT ADEQUATELY SEAL A VESSEL. AS A RESULT, BLEEDING WAS OBSERVED. ON 02-NOV-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A SITE ROBOTICS NURSE, STEMMING FROM INFORMATION PROVIDED BY OPERATING ROOM (OR) STAFF WHO WERE PRESENT FOR THE CASE: THE SYNCHROSEAL INSTRUMENT DID NOT ACTIVATE AT ONE TIME DURING THE SURGICAL PROCEDURE BUT THE PHYSICIAN CONTINUED TO USE THE DEVICE. A SECOND BACKUP INSTRUMENT WAS NOT OPENED AND USED DURING THE CASE. THE ROBOTICS NURSE IS UNSURE OF THE AMOUNT OF BLOOD LOSS AND CONFIRMED THAT THE INSTRUMENT WAS RETURNED FOR EVALUATION. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "326732301", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "326732302", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D10, D02: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT THAT THE INSTRUMENT MISFIRED AND DID NOT SEAL ON A VESSEL. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH THE FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP OPENED AND CLOSED PROPERLY. ENERGY WAS DELIVERED WITHOUT ANY ISSUE AND THE ELECTRICAL CONTINUITY TEST PASSED. THE INSTRUMENT PASSED THE GRIP FORCE TEST. THE ROOT CAUSE IS NON DEVICE-RELATED FACTORS. AN ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS ALSO OBSERVED. A VISUAL INSPECTION WAS CONDUCTED AND THERMAL DAMAGE WAS FOUND ON THE CUT ELECTRODE. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT WAS FOUND WITH MINOR CUT ELECTRODE THERMAL DAMAGE LIKELY DUE TO AN ARCING EVENT CAUSED BY THE BIPOLAR CUT FUNCTION. THE SEAL ELECTRODE WAS UNDAMAGED, AND CHARRING INDICATES THE ARC REMAINED IN THE JAWS OF THE INSTRUMENT. NO FURTHER DAMAGE WAS FOUND. THE GENERATOR LOGS WERE PULLED AND ANALYZED, THE INSTRUMENT WAS ONLY USED FOR ACTIVATIONS. THE FIRST ACTIVATION RECORDED A 'TRANSECT TIMEOUT' ERROR- INDICATING THAT ENERGY WAS DELIVERED FOR THE MAXIMUM ALLOWABLE TIME. AS THE INSTRUMENT PASSED THE ENERGY DELIVERY AND CONTINUITY TEST, THIS MESSAGE SUGGESTS THE USER MAY HAVE BEEN FIRING ACROSS A METAL OR CONDUCTIVE OBJECT (CLIP, STAPLE, SUBMERSED IN FLUID, ETC) AND DIRECTLY SHORTING THE INSTRUMENT JAWS." } ], "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": "12/10/2021" } ] }