{ "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": "2955842-2023-13030", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20230511", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230413", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20230511", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220728", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "817757", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230511", "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": "480440-06", "catalog_number": "480440", "lot_number": "L11220731 0176", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)240731(10)L11220731", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/11/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20230511", "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": "20230414", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16914423", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20230414", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other", "Notification" ], "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": "336452299", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 11-MAY-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE REPORTED EVENT: THE ISSUE OCCURRED DURING THE ROBOTIC PROCEDURE WHEN THE SYNCHOSEAL INSTRUMENT SYNCH ACTIVATION WAS USED TO ACHIEVE HEMOSTASIS OF THE PULMONARY ARTERY BUT DID NOT SUFFICIENTLY SEAL, LEADING TO UNEXPECTED BLEEDING AFTER WOUND CLOSURE. THE PULMONARY ARTERY WAS CLOSE TO 5MM IN DIAMETER, THE NECK WAS SHORT, AND THERE WAS A RISK OF TENSION TO THE VESSEL. NO PROBLEMS WERE NOTED DURING THE ROBOTIC PROCEDURE. THE SURGEON MADE THE CLINICAL DECISION TO PERFORM ADDITIONAL THORACOTOMY DUE TO HEAVY BLEEDING. ESTIMATED BLOOD LOSS WAS 2L AND 4 UNITS OF RED CELL CONCENTRATES (RCC) WERE ADMINISTERED. HEMOSTASIS WAS ACHIEVED WITH THORACOTOMY. THE SURGEON BELIEVES THERE IS A POSSIBILITY THAT THE SEALED PULMONARY ARTERY RUPTURED DUE TO STRAINING DURING EXTUBATION (DUE TO PATIENT COUGHING). THE SURGEON BELIEVES THAT BLOOD LOSS OCCURRED DUE TO THE DETACHMENT OF VESSELS SEALED BY THE SYNCHROSEAL. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. AT THE TIME OF THE PULMONARY ARTERY HEMOSTASIS, DURING THE SEALING SEQUENCE, THERE WAS A CONTINUOUS TONE WHILE THE PEDAL WAS PRESSED. IT IS UNKNOWN WHETHER THREE ASCENDING FAST AUDIBLE TONES WERE HEARD SUGGESTING SEALING OR SYNC MODE CYCLE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHETHER TISSUE EFFECT WAS OBSERVED DURING THE SEALING/SYNCH CYCLE. THE SYNCHOSEAL INSTRUMENT JAWS DID NOT ENCOUNTER A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE ISSUE OCCURRED. THE INSTRUMENT JAWS WERE NOT IMMERSED IN A LIQUID OR CONTAMINATED BY BIO DEBRIS PRIOR TO OR DURING THE SEALING CYCLE. THERE WERE NO UNEXPECTED MOVEMENTS OF THE SYNCHROSEAL THAT CAUSED THE BLEEDING. THE SYNCHROSEAL IS NOT AVAILABLE FOR RETURN." }, { "mdr_text_key": "336452300", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "315064789", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE AND CLOSURE OF PORT(S), THE PATIENT'S BLOOD PRESSURE DROPPED. AS A RESULT, THE PATIENT UNDERWENT OPEN SURGERY TO CONTROL BLEEDING. HEMOSTASIS WAS ACHIEVED. THE SOURCE OF THE BLEEDING IS UNCLEAR. HOWEVER, IT WAS REPORTED THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON HAD USED A SYNCHOSEAL INSTRUMENT ON THE PULMONARY ARTERY (PA). THE STATUS OF THE PATIENT¿S LUNGS IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "315064790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS WAS COMPLETED, AND NO RELATED SYSTEM ERRORS WERE OBSERVED. A REVIEW OF THE SYNCHROSEAL INSTRUMENT LOG SHOWED THAT IT WAS USED FOR ABOUT 26 MINUTES. E-100 LOGS SHOW ONLY 12 EVENTS IN TOTAL (7 TRANSECTION EVENTS, 4 COAGULATION EVENTS AND 1 SEAL EVENT). ALL EVENTS WERE COMPLETED WITH NO ERRORS. IT IS INDETERMINABLE WHAT COULD HAVE LED TO INSUFFICIENT SEALING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, THE PATIENT UNDERWENT A SUBSEQUENT UNPLANNED PROCEDURE AFTER EXPERIENCING A DROP IN BLOOD PRESSURE. THE SURGEON PERFORMED OPEN SURGERY TO CONTROL BLEEDING. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "06/06/2023" } ] }