{ "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": "2955842-2024-13136", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240408", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240312", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20240409", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230831", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2289436", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240408", "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": "L10230831 0201", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240320", "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)250831(10)L10230831", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/15/2024;07/09/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250820", "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": "20240408", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240311", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19068583", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240311", "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": "342419188", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "342419189", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FAILURE ANALYSIS TESTING WAS COMPLETED AND THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THE WASHER DISLODGED FROM ITS ORIGINAL POSITION AND NOT ATTACHED TO THE INSTRUMENT. THE INSTRUMENT WAS COMPARED TO AN IN-HOUSE SYNCHROSEAL INSTRUMENT, AND THE WASHER WAS FOUND TO BE MISSING. THE MISSING PIECE WAS RETURNED WITH THE INSTRUMENT. NO FAILURES WERE FOUND IN THE LOGS." }, { "mdr_text_key": "347181347", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHRO SEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ADDITIONAL FAILURE ANALYSIS INVESTIGATIONS. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DISTAL WASHER DISLODGED TO BE RELATED TO THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THE WASHER DISLODGED FROM ITS ORIGINAL POSITION AND NOT ATTACHED TO THE INSTRUMENT. THE INSTRUMENT WAS COMPARED TO AN IN-HOUSE SYNCHRO SEAL, AND THE WASHER WAS FOUND TO BE MISSING FROM THE INSTRUMENT, BUT WAS RETURNED. THE PIVOT PIN WAS INSPECTED, AND NO ISSUES WERE SEEN WITH THE SWAGE AND MACHINE ENDS. NO FAILURES WERE FOUND IN THE LOGS. ADDITIONALLY, INITIAL FAILURE ANALYSIS FINDINGS WERE CONFIRMED. ONE OF THE WASHERS AT THE DISTAL END WAS FOUND TO BE DISLODGED. NO ISSUES WERE FOUND WITH THE SWAGING OR MACHINE ENDS OF THE PIVOT PIN. NO DAMAGE TO THE JAW COVER WAS OBSERVED, AND THE WASHER DID NOT APPEAR SCRATCHED OR DAMAGED." }, { "mdr_text_key": "347181348", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "339670677", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE WASHER FELL OFF THE WRIST OF THE INSTRUMENT AND IT WAS RETRIEVED IN THE SAME PROCEDURE. THE REPORTER STATED THAT THE FRAGMENT WAS PICKED UP BY ANOTHER FORCEPS INSTRUMENT AND WAS CONFIRMED VISUALLY. THE REPORTER DENIED KNOWLEDGE OF THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE EVENT. THE REPORTER CONFIRMED THAT THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE IS NO REPORT OF POST-SURGICAL COMPLICATIONS AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE SURGEON COMMENTED THAT THERE WAS NOTHING ELSE THAT HAD FALLEN INSIDE THE PATIENT. THE REPORTER CLAIMED TO HAVE NO KNOWLEDGE OF INSTRUMENT COLLISION, ANY FRAGMENT FALLS DURING THE INSTRUMENT COLLISION, OR THE INSTRUMENT BEING REMOVED BEFORE THE BREAKAGE OCCURRED. THE REPORTER WAS NOT AWARE OF FEELING ANY RESISTANCE WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED AND THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT." }, { "mdr_text_key": "339670678", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE." } ], "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": "05/13/2024;07/16/2024" } ] }