{ "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": "2955842-2021-10012", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210108", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20201209", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210108", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190201", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "39634", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210108", "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": "M10190210 0384", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210208", "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)210131(10)M10190210", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/09/2021;12/15/2020", "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": "20210108", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "No Clinical Signs, Symptoms or Conditions", "Device Embedded In Tissue or Plaque", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20201215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11137568", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201215", "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": "323360375", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11 - INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF \"PART OF THE HARMONIC INSTRUMENT BROKE OFF\" TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.137¿ FROM THE BASE ND THE BROKEN PIECE WAS RETURNED. 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 CAUSE OF THE INSTRUMENT BREAKAGE WAS ATTRIBUTED TO MISHANDLING/MISUSE. A LOG REVIEW WAS PERFORMED AND REVEALED THAT THE INSTRUMENT WAS NOT USED ON THE REPORTED EVENT DATE OF (B)(6) 2020. INSTEAD, THE INSTRUMENT WAS USED ON (B)(6) 2020. THE EVENT DATE WAS UPDATED BASED ON THIS NEW INFORMATION." }, { "mdr_text_key": "335844757", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335844758", "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 PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "241680289", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) 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 FOR ADDITIONAL INFORMATION RECEIVED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. VERIFICATION OF THE PRODUCT AND EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE WAS INSUFFICIENT PRODUCT INFORMATION PROVIDED. A SITE HISTORY REVIEW WAS PERFORMED AND NO RELATED COMPLAINTS WERE FOUND TO THE PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DAVINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM THE HARMONIC ACE INSTRUMENT FELL INSIDE THE PATIENT, AND WAS RETRIEVED. WHILE THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY, AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. ADDITIONALLY, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "241680290", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE A FRAGMENT COME OFF THE HARMONIC ACE INSTRUMENT AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. IT WAS CONFIRMED THAT THE FRAGMENT WAS RETRIEVED USING ANOTHER INSTRUMENT AND THE SURGEON VERIFIED THE FRAGMENT WAS REMOVED. THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE. THE SURGEON WAS NOT SURE WHAT CAUSED THE ISSUE. THERE WAS NO INSTRUMENT COLLISION NOTED AND NO INDICATION OF CANNULA DAMAGE. THE INSTRUMENT WRIST WAS NOTED TO BE STRAIGHTENED UPON REMOVAL. THERE WAS NO PATIENT HARM AND NO POST-OPERATIVE COMPLICATIONS. NO IMAGE OR VIDEO RECORDING WERE AVAILABLE. NO FURTHER DETAILS WERE AVAILABLE." } ], "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": "03/07/2021;05/24/2023" } ] }