{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2014-03194", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20140523", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20140221", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140523", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "308578", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140523", "brand_name": "HARMONIC ACE, DA VINCI INSERT", "generic_name": "ELECTROSURGICAL INSTRUMENT ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "400272-02", "catalog_number": "", "lot_number": "M10130813", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20140515", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20140523", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20140425", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3830133", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140425", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "11895637", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE HARMONIC INSERT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE HARMONIC INSERT TO BE BROKEN. THE MISSING INSERT BLADE WAS BROKEN OFF WHICH MEASURED APPROXIMATELY 0.256. THERE WAS NO SIGN OF FORCED IMPACT ON THE INSERT. THE INSERT ALSO EXHIBITED SOME BIO DEBRIS. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE DA VINCI HARMONIC ACE CURVED SHEARS INSTRUCTIONS FOR USE SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE DEVICE IS ACTIVATED. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY A GENERATOR SOLID TONE OR AN INSTRUMENT ERROR. HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PIECE OF THE HARMONIC ACE INSERT INSTRUMENT ALLEGEDLY BROKE OFF INTO THE PATIENT AND THE FRAGMENT WAS RETRIEVED. AN X-RAY WAS PERFORMED AND NO FRAGMENTS WERE SEEN TO REMAIN IN THE PATIENT. AT THIS TIME, IT IS UNKNOWN HOW THE BROKEN FRAGMENT WAS RETRIEVED." }, { "mdr_text_key": "4446641", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI GASTRECTOMY SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE HARMONIC ACE INSERT WAS SUDDENLY BROKEN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER TO ASK FOR ADDITIONAL INFORMATION, THE CUSTOMER INDICATED THAT A FRAGMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. AN X-RAY WAS PERFORMED AND NO FRAGMENTS WERE SEEN TO REMAIN IN THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }