{ "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": "2955842-2026-25892", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260521", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20260301", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260521", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251204", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "316019", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260521", "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": "480440-07", "catalog_number": "480440", "lot_number": "K12251204", "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": [ "Detachment of Device or Device Component" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/01/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260521", "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" ] } ], "distributor_city": "", "date_report": "20260609", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25240850", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260428", "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": "401886944", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A DA VINCI-ASSISTED PARTIAL HEPATECTOMY SURGICAL PROCEDURE, A SMALL PIECE OF THE SYNCHROSEAL INSTRUMENT WAS FOUND TO BE REMOVED FROM THE JAW PART AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. IT WAS RETRIEVED DURING THE SAME PROCEDURE. AFTER FURTHER INSPECTION, THE PIECE APPEARED TO BE A LAYER OF PLASTIC FROM THE INSTRUMENT JAW. IT WAS UNKNOWN WHETHER ANY POST-OPERATIVE DIAGNOSTIC TESTS HAS BEEN PERFORMED TO CONFIRM THE FRAGMENT RETRIEVED COMPLETELY. ON 28-APR-2026, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) STATING: \"DURING LAST BITE/SEAL OF EXCISING SPECIMEN, A SMALL PIECE WAS FOUND TO HAVE BEEN REMOVED FROM THE JAW- PART OF THE SUPPLY/INSTRUMENT ITEM- AND FELL INTO THE ABDOMINAL CAVITY. IT WAS NOTICED AND REMOVED IMMEDIATELY. AT FIRST, THE TEAM THOUGHT IT WAS CHAR, BUT AFTER FURTHER INSPECTION THE PIECE APPEARS TO BE A LAYER OF PLASTIC FROM THE INSTRUMENT JAW.\"" }, { "mdr_text_key": "401886945", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. ." }, { "mdr_text_key": "407434985", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A ROBOT-ASSISTED PARTIAL HEPATECTOMY. THE FRAGMENT WAS DIRECTLY VISUALIZED AT THE TIME IT FELL, AND IT WAS CONFIRMED THAT ALL FRAGMENTS WERE ACCOUNTED FOR AND RETRIEVED MANUALLY, ENSURING THAT NO PIECES REMAINED IN THE PATIENT¿S ABDOMEN. NO POST-OPERATIVE IMAGING (E.G., X-RAY OR ULTRASOUND) WAS PERFORMED. ADDITIONALLY, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE CUSTOMER STATED THAT NEITHER THE INSTRUMENT NOR THE RETRIEVED FRAGMENT IS AVAILABLE FOR RETURN TO INTUITIVE. THE CUSTOMER ALSO CONFIRMED THAT NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE PROCEDURE ARE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "407434986", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/09/2026" } ] }