{ "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": "2955842-2020-11395", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201223", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20201124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20201223", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200709", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1527095", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201223", "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": "M90200713 0161", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201229", "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)220731(10)M90200713", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Detachment of Device or Device Component", "Break", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/29/2020;11/26/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "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": "20201223", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "15 YR", "patient_sex": "Female", "patient_weight": "76 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201126", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11062372", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201126", "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": "321981851", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "61 - THE HARMONIC ACE HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. ONE OF THE BLADE EDGES EXHIBITED MECHANICAL INDENTATIONS/SCRATCH MARKS. THE DAMAGED BLADE WAS MISSING SOME MATERIAL FROM THE DISTAL END. SIZE OF MISSING MATERIAL WAS APPROXIMATELY 0.011\" X 0.020\" AND WAS NOT RETURNED WITH THE INSTRUMENT. SCRATCHES ON THE BLADE TIP MAY LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE ROOT CAUSE OF THIS FAILURE IS FATIGUE FAILURE DUE TO USER MISHANDLING/MISUSE. IN ADDITION, THE INSTRUMENT WAS FOUND TO HAVE THE THERMAL PAD DAMAGED. NO MATERIAL WAS MISSING AS A RESULT OF THE DAMAGE. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING." }, { "mdr_text_key": "336071646", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A ADVERSE EVENT, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "336071647", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "228667883", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "SI HAS NOT YET RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE FULL INSTRUMENT LOT NUMBER WAS NOT PROVIDED. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE SHOWS METAL SHAVINGS INSIDE THE PATIENT AND A BLURRY VIEW OF THE HARMONIC ACE INSTRUMENT. IT IS IMPOSSIBLE TO TELL FROM THESE PICTURES ALONE WHAT THE SOURCE OF THE SHAVINGS IS AND IF THESE WERE GENERATED FROM MISHANDLING/MISUSE. THE INSTRUMENT SHOULD BE RETURNED FOR FAILURE ANALYSIS. A REVIEW OF THE SUBMITTED PROCEDURE VIDEO WAS PERFORMED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE): VIDEO V0001- THERE WAS A COLLISION OF THE HARMONIC ACE AND PROGRASP FORCEPS JAWS AT 23:05. THE HARMONIC ACE WAS ACTIVATED WHILE IN CONTACT WITH A METAL CLIP AT 29:55. BOTH OF THESE BEHAVIORS ARE WARNED AGAINST IN THE USER MANUAL SINCE COLLISIONS AND ACTIVATION ON A METAL OBJECT MAY CONTRIBUTE TO INSTRUMENT DAMAGE RESULTING IN FRAGMENTS. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, METAL FRAGMENTS WERE FOUND INSIDE THE PATIENT WHEN A HARMONIC ACE INSTRUMENT WAS IN USE. THE FRAGMENTS WERE NOT RETRIEVED. AT THIS TIME, THE SOURCE OF THE METAL FRAGMENTS HAS NOT BE DETERMINED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "228667884", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, METAL FRAGMENTS WERE FOUND INSIDE THE PATIENT WHEN A HARMONIC ACE INSTRUMENT WAS IN USE. THE FRAGMENTS WERE NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE NOT RETRIEVED BECAUSE THEY WERE SO TINY. NO POST-OPERATIVE TESTS WERE PERFORMED. THE INSTRUMENT WAS IN USE FOR ABOUT 50 MINUTES PRIOR TO THE ISSUE AND WAS INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE HARMONIC ACE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE FRAGMENTS BEING IDENTIFIED. UPON THE 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 NOTICED TINY SCRATCHES ON THE BLADE OF THE HARMONIC ACE INSTRUMENT AFTER THE EVENT OCCURRED. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." } ], "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": "01/21/2021;05/24/2023" } ] }