{ "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": "2955842-2024-23516", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241226", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20241204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241226", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240919", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1730796", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241226", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-06", "catalog_number": "480440", "lot_number": "K14240919", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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)260930(10)K14240919", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "KY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/02/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241226", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20241205", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21021176", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241205", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "363031004", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT AND PERFORMED FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE THE JAW COVER TORN. THE MISSING TEARS MEASURED ROUGHLY 0.1435\" X 0.1065\". THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS UPON MANUAL ARTICULATION. THE JAWS DID NOT OPEN AND CLOSE PROPERLY AS THE COVER IS EXTENDED TO THE BASE OF THE JAWS. THE INSTRUMENT WAS ALSO RETURNED WITH THE POWER CORD CUT OFF AND MISSING. A VISUAL INSPECTION DID NOT REVEAL ANY THERMAL DAMAGE OR SIGNS OF \"MELTING.\" THE ROOT CAUSE IS ATTRIBUTED TO USER. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON 4-DEC-2024 ON SYSTEM RSK8069 ON ARM 2. A DHR REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS OBTAINED, THEN THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION." }, { "mdr_text_key": "363031005", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "360051439", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "360051440", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, A TINY ROUND PIECE CAME OFF OF THE SYNCHROSEAL INSTRUMENT AND FELL INSIDE PATIENT. THE DOCTOR VISUALIZED AND REMOVED THE FALLEN PIECE. THE INSTRUMENT WAS REMOVED AND EXCHANGED FOR A NEW ONE. THE PROCEDURE WAS COMPLETED ROBOTICALLY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/27/2025" } ] }