{ "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": "2955842-2023-18742", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230926", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20230824", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20230926", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230112", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1097500", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230926", "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": "L10230115 0130", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230907", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)250131(10)L10230115", "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", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20230926", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230828", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17818822", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230828", "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": "324279078", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE SYNCHROSEAL INSTRUMENT HAD PARTS THAT WERE FALLING OFF FROM THE HINGES. IT WAS NOTED THAT FRAGMENTS FELL INSIDE THE PATIENT AND WERE RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES FOUND. AT THE TIME OF THE REPORTED EVENT OF THE FRAGMENT FALLING INSIDE THE PATIENT, THE SURGICAL TASK THAT WAS BEING PERFORMED WAS DISSECTING AND GRASPING. THE FRAGMENT(S) WERE ABLE TO BE REMOVED BY USING \"LAPALO FORCEPS\" BY THE ASSISTANT DOCTOR, AND ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN REMOVED FROM THE BODY. POST-OPERATIVE X-RAYS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON COMMENTED THAT A SIMILAR PHENOMENON HAD OCCASIONALLY OCCURRED WITH A THIRD COMPANY'S PRODUCTS. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE SYNCHROSEAL. THERE WAS NO INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. AT ONE TIME DURING THE PROCEDURE AND PRIOR TO THE BREAKAGE, THE SYNCHROSEAL INSTRUMENT WAS REMOVED AND THE INSTRUMENT'S WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. THERE WAS NO DAMAGE THAT WAS FOUND TO THE CANNULA, OR ANY ADDITIONAL DAMAGE THAT WAS FOUND ON THE INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR HARM. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "324279079", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT AND PERFORMED FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT'S JAW COVER WAS FOUND TO BE DISLODGED, AND THE WASHER LOCATED ON THE OUTSIDE OF THE JAW COVER WAS DISLODGED. THE WASHER WAS RETURNED WITH THE SYNCHROSEAL INSTRUMENT. A VISUAL INSPECTION THAT WAS CONDUCTED FOUND ALL CERAMIC DOTS IN PLACE. A REVIEW OF THE LOGS FOUND NO ERROR CODES RELATED TO THE SYNCHROSEAL INSTRUMENT." } ], "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": "" } ] }