{ "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": "2955842-2024-12009", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240301", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20240205", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240301", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220127", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "296986", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240301", "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": "L90220130 0011", "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": "", "udi_public": "", "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 Separation", "Material Fragmentation", "Material Separation" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/01/2024;03/29/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20240301", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "72 YR", "patient_sex": "Female", "patient_weight": "90 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240205", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18818635", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240205", "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": "336685040", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ." }, { "mdr_text_key": "336685041", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 02/26/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5151229 STATING: \"SMALL SCREW FROM DAVINCI SYNCHROSEAL FELL OFF INSIDE PATIENT. SURGEON REMOVED SCREW IMMEDIATELY. DAVINCI REP MADE AWARE. DEVICE REMOVED FROM THE FIELD.\"" }, { "mdr_text_key": "340162181", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION/DEVICE EVALUATION: INITIAL FAILURE ANALYSIS: THE PRODUCT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) FOUND THE PRIMARY FAILURE OF DISLODGED DISTAL WASHER BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE ONE OF THE DISTAL WASHERS TO BE DISLODGED. THE DISLODGED DISTAL WASHER WAS NOT RETURNED WITH THE INSTRUMENT. THE HOUSING WAS REMOVED AND THERE WERE NO MISSING SCREWS AT THE PROXIMAL END. ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS RELATED TO THE PRIMARY FAILURE: THE INSTRUMENT WAS MISSING THE JAW COVER. DEMOGRAPHICS: DATE OF BIRTH (B)(6) 1951, FEMALE, 90.3 KG, PREVIOUS HISTORY OF HIATAL HERNIA. IMAGE REVIEW: BASED ON THE IMAGES PROVIDED WE CAN CONFIRM THAT THE SYNCHROSEAL IN IMAGE 2 IS MISSING THE WASHER THAT WAS RETRIEVED AND IS PICTURED IN THE PLASTIC CUP IN IMAGE 1. ANNEX B: ADDED B15 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY AND B01 - TESTING OF ACTUAL/SUSPECTED DEVICE." }, { "mdr_text_key": "340162182", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "340925887", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION: ADVANCED FAILURE ANALYSIS WAS PERFORMED AND THE INITIAL FAILURE ANALYSIS FINDINGS WERE CONFIRMED. THE DISTAL WASHER WAS FOUND TO BE DISLODGED. THE JAW COVER WAS ALSO CONFIRMED TO BE MISSING, BUT IT ISN'T NECESSARILY RELATED TO THE PRIMARY CODE OF DISTAL WASHER DISLODGED. THE WRIST DISCS WERE DISASSEMBLED, AND REMNANTS OF THE RUBBER WASHER WERE FOUND IN THE AREA AROUND WRIST DISCS, INDICATING THAT THE JAW COVER LIKELY CAME LOOSE DUE TO COLLISIONS WITH OTHER INSTRUMENTS ETC. DURING THE PROCEDURE, AND UNLIKELY THAT IT WAS NEVER INSTALLED DURING MANUFACTURING. ADDITIONALLY, THE PIVOT PIN WAS INSPECTED, AND IT LOOKED APPROPRIATELY SWAGED. CORRECTION: ANNEX D - RETRACT CODE D15." } ], "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": "03/26/2024;04/23/2024" } ] }