{ "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": "2955842-2025-46212", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20251126", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20251126", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "318044", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251126", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Cut", "Failure to Cut" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/28/2025;02/25/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260309", "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": "20251126", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260304", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23659075", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251030", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "394754957", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: H2 AND H11. ADDITIONAL INFORMATION: ADDITIONAL REVIEW OF THE CUSTOMER PROVIDED IMAGES SHOWS THAT IN THE FIRST IMAGE, THE SYNCHROSEAL INSTRUMENT IS SHOWN GRASPING TISSUE. IN THE SECOND IMAGE, TISSUE IS VISIBLE WITH CHARRING THAT MATCHES THE SHAPE OF THE INSTRUMENT JAWS; HOWEVER, THE TISSUE DOES NOT APPEAR TO BE TRANSECTED. WHEN THE BLUE PEDAL IS PRESSED, SYNCHROSEAL WILL SEAL OR SPOT COAGULATE THE TISSUE. PRESSING THE YELLOW PEDAL ACTIVATES THE SYNC FUNCTION, WHICH BOTH SEALS AND TRANSECTS. UNFORTUNATELY, THE PROVIDED IMAGES DO NOT INDICATE WHICH PEDAL THE SURGEON PRESSED, SO IT IS NOT POSSIBLE TO DETERMINE WHETHER THE INSTRUMENT FAILED TO CUT." }, { "mdr_text_key": "394754958", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390706863", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390706864", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: H2, H6, H11. ADDITIONAL INFORMATION: THE ISSUE OCCURRED WHILE IN SYNC MODE, AND RESULTED IN CHARRED TISSUE THAT WAS NOT SEPARATED. A REVIEW OF AN IMAGES PROVIDED BY THE CUSTOMER SHOWS THAT THERE IS NO OBVIOUS DAMAGE TO THE INSTRUMENT." }, { "mdr_text_key": "386168893", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN UNSPECIFIED NUMBER OF DA VINCI-ASSISTED PROCEDURES, THE SYNCHROSEAL INSTRUMENT WOULD NOT ADEQUATELY CUT TISSUE AND INSTEAD ¿CHEWED¿ THE TISSUE. IN INCIDENTS WHERE THE SYNCHROSEAL INSTRUMENT DID SUCCESSFULLY CUT TISSUE, THIS WAS ONLY ACHIEVED BY APPLYING MAXIMUM TRACTION-COUNTERTRACTION. AS A RESULT, THE PARTIALLY UNCUT TISSUE WOULD TEAR CAUSING MINIMAL BLEEDING; HOWEVER, NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED TO MANAGE THE TISSUE DAMAGE OR BLEEDING. AT NO TIME WAS TISSUE CUT WITHOUT BEING FULLY SEALED, AND NO ADDITIONAL TISSUE REMOVAL WAS NECESSARY. THE FOLLOWING INFORMATION IS UNKNOWN: THE PROCEDURE TYPES, WHAT TISSUE OR VESSEL WAS SPECIFICALLY INJURED, SPECIFIC AMOUNT OF BLEEDING, OR HOW THE PROCEDURES WERE COMPLETED." }, { "mdr_text_key": "386168894", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. INSUFFICIENT INFORMATION IS AVAILABLE FOR PROCEDURE VERIFICATION; THEREFORE, NO DA VINCI SYSTEM OR INSTRUMENT LOGS ARE AVAILABLE FOR REVIEW." } ], "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": "12/22/2025;03/04/2026" } ] }