{ "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": "2955842-2021-10022", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210111", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20201207", "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": "WANG", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210111", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200723", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "42388", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210111", "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": "M90200726", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)220731(10)M90200726", "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": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/18/2020", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20210111", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "60 YR", "patient_sex": "Female", "patient_weight": "62 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11152668", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201218", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "267863554", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A LOG REVIEW CONFIRMED THAT THE HARMONIC ACE INSTRUMENT WITH LOT NUMBER M 90200726 -0009 WAS USED IN A LIVER RESECTION PROCEDURE ON SYSTEM SK 1463 WITH A PROCEDURE DATE OF (B)(6) 2020. THE HARMONIC ACE IS A SINGLE USE INSTRUMENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "267863555", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE CUSTOMER REPORTED THAT THE HARMONIC ACE INSTRUMENT TIP FROM THE JAWS FELL OFF INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE OCCURRED WITH THE THIRD \"PASSING\" OF THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED BEFORE USE AND THERE WAS NO VISIBLE DAMAGE NOTED. THE INSTRUMENT TIP BROKE OFF DURING LIVER MOBILIZATION. THE SURGEON SAW THE TIP BREAK OFF IN ONE PIECE AND USED A LAPAROSCOPIC GRASPER DURING THE SAME SURGERY TO REMOVE THE FRAGMENT. NO POST-OPERATIVE INVESTIGATION WAS DONE AFTER THE PROCEDURE AS IT WAS DEEMED NOT NECESSARY. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE INSTRUMENT AND NO COLLISION OF THE INSTRUMENT WITH ANY HARD MATERIAL BEFORE THE TIP BROKE OFF. THE SURGEON BELIEVES THE INSTRUMENT TIP BROKE OFF DUE TO A DEFECTIVE INSTRUMENT. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE, WEIGHING (B)(6) KG. DATE OF BIRTH WAS (B)(6) 1960. RACE AND ETHNICITY WERE UNKNOWN. RELEVANT MEDICAL HISTORY AND INVESTIGATIONS WERE REQUESTED BUT NOT PROVIDED BY THE CUSTOMER." }, { "mdr_text_key": "336871536", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336871537", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." } ], "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": "05/24/2023" } ] }