{ "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": "2955842-2022-12954", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220714", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20220509", "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": "TW", "manufacturer_contact_area_code": "408", "date_added": "20220714", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211220", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "408534", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220714", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "L90220104 0279", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220616", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)231231(10)L90220104", "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": "20250808", "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": "20220714", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220614", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15018067", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220614", "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": "295954520", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND A CRACK ON THE HARMONIC ACE INSTRUMENT JAW. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. NO INSTRUMENT COLLISION WAS OBSERVED DURING THE PROCEDURE. THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON WAS MAKING AN INCISION AT THE TIME OF THE EVENT. THE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS LOCATED AND RETRIEVED WITH LAPAROSCOPIC INSTRUMENT FORCEPS DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE BREAKAGE. THERE WAS NO RESISTANCE UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT OR CANNULA AFTER THE EVENT OCCURRED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. A VIDEO RECORDING OF THE PROCEDURE IS NOT AVAILABLE, BUT AN IMAGE OF THE INSTRUMENT DAMAGE WAS PROVIDED." }, { "mdr_text_key": "295954521", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REVEALED THAT THE INSTRUMENT CURVED BLADE WAS FOUND TO BE BROKEN NEAR THE BASE OF THE BLADE. THE BLADE BROKE AT ROUGHLY 0.226¿ FROM THE BASE. THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE ROOT CAUSE OF THE ¿BROKEN INSTRUMENT BLADES¿ IS TYPICALLY DUE TO MISHANDLING/MISUSE. A REVIEW OF THE LOGS SHOWED THE HARMONIC ACE INSTRUMENT (PART# 480275-08 / LOT# L90220104-0279) WAS LAST USED ON (B)(6) 2022 DURING THIS THYROIDECTOMY SURGICAL PROCEDURE WITH SYSTEM SK4466. THE HARMONIC ACE INSTRUMENT IS A SINGLE-USE DEVICE. IMAGES OF THE HARMONIC ACE INSTRUMENT RELATED TO THIS EVENT WERE RECEIVED AND REVIEWED. THE IMAGE CONFIRMED THAT THE HARMONIC ACE INSTRUMENT BLADE WAS MISSING/DETACHED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." } ], "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": "" } ] }