{ "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": "2955842-2024-16647", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240710", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20240611", "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", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20240710", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231026", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "363141", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240710", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "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": "480275-08", "catalog_number": "480275", "lot_number": "L82231026", "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": "10886874112738", "udi_public": "(01)10886874112738(17)251031(10)L82231026", "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": "08/07/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20240710", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240611", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19713157", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240611", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "350290286", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "350290287", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BLADE BROKEN AT THE MIDPOINT. A PIECE APPROXIMATELY 2.1 MM X 11 MM WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE." }, { "mdr_text_key": "346592741", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC SCISSORS BROKE OFF AND FELL INTO THE SITUS. HOWEVER, IT WAS SUCCESSFULLY RECOVERED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. WHEN PREPARING THE INSTRUMENTS, THE INSTRUMENT FRAGMENT FELL INSIDE THE PATIENT. THE PROBABLE CAUSE OF THE EVENT WAS DETERIORATION. THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE FOR ONE HOUR AND A HALF. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED WITH A SMALL SALVAGE BAG. ALL THE FRAGMENTS WERE RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE FRAGMENT THAT WAS RETRIEVED, WAS ALSO RETUNED BACK TO INTUITIVE." }, { "mdr_text_key": "346592922", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED." } ], "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": "08/25/2024" } ] }