{ "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": "2955842-2022-13405", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220811", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220712", "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": "20220811", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220428", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1721493", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220811", "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": "L91220501 0067", "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)240430(10)L91220501", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Defective Device", "Defective Device" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220811", "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": "20220712", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15212714", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220712", "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": "297759389", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WENT ONTO THE SITE AND COULD NOT REPLICATE THE REPORTED ISSUE. THE E-100 GENERATOR WAS REPLACED AS PRECAUTION. THE E-100 GENERATOR WAS RETURNED TO ISI AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE REPORTED FAILURE OF THE GENERATOR POWERING OFF. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND IT WORKED FINE WITH A SYNCHROSEAL INSTRUMENT INSTALLED. THE SYNCHROSEAL INSTRUMENT WAS ABLE CUT/SEAL ABOUT 100 TIMES WITH THE E-100 GENERATOR WITHOUT ANY ISSUES. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. NO IMAGE OR VIDEO OF THE EVENT WAS PROVIDED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS NOT RESPONDING CORRECTLY AND WOULD NOT OPEN. IN ADDITION, THE E-100 SHUT OFF UNEXPECTEDLY AND BLEEDING WAS OBSERVED. THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY DUE TO BLOOD LOSS AND TO CONTROL THE BLEEDING. THE CAUSE OF THE BLEEDING IS UNKNOWN." }, { "mdr_text_key": "297759390", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE E-100 GENERATOR TURNED OFF UNEXPECTEDLY AND WHEN THE SURGEON WAS ATTEMPTING TO USE THE SYNCHROSEAL INSTRUMENT, THE SURGEON REPORTED HAVING TROUBLE MOVING THE INSTRUMENT. THE SURGEON INDICATED THAT THE INSTRUMENT WAS NOT WORKING OR RESPONDING CORRECTLY AND WOULD NOT OPEN. BY THE TIME THE SURGICAL STAFF TURNED THE GENERATOR BACK ON, THE SURGEON HAD REPORTEDLY OBSERVED BLEEDING AND ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER THE ISSUE OCCURRED WITH THE SYNCHROSEAL INSTRUMENT, THE SURGICAL STAFF OPENED A SECOND SYNCHROSEAL INSTRUMENT. THE SURGEON WAS ABLE TO USE THE BACKUP SYNCHROSEAL INSTRUMENT WITHOUT ANY ISSUES. HOWEVER, THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY DUE TO BLOOD LOSS AND TO CONTROL BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT PROVIDED. HOWEVER, THE SURGEON MENTIONED THAT THE DA VINCI SYSTEM WAS A CONTRIBUTING FACTOR TO THE INTRA-OPERATIVE COMPLICATION SINCE HE COULD NOT CONTROL BLEEDING AND WAS UNABLE TO CAUTERIZE. THE SOURCE OF THE BLEEDING WAS ¿UTERINE VESSELS WITH BACK BLEEDING.¿ THE ESTIMATED BLOOD LOSS FROM UTERUS AND VESSELS WAS 900CC. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. THE PATIENT TOLERATED THE OPEN SURGERY WELL AND WAS DISCHARGED ON POST-OPERATIVE DAY (POD) #1. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED." } ], "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": "" } ] }