{ "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": "2955842-2020-10736", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200812", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200713", "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": [ "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": "20200812", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20191113", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "861012", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200812", "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": "M90191117 0321", "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)211130(10)M90191117", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/17/2020", "mfr_report_type": "Initial", "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": "20200812", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "41 YR", "patient_sex": "Female", "patient_weight": "65 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200717", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10394575", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200717", "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": "335840951", "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": "335840952", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "233717668", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION BECAUSE IT WAS DISCARDED BY THE SITE. THEREFORE THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE PRODUCT ASSOCIATED WITH THIS EVENT SHOWS THAT THE HARMONIC ACE WAS LAST USED ON (B)(6) 2020 ON SYSTEM #(B)(4). BASED ON THIS REVIEW, THE INSTRUMENT WAS NOT USED IN SUBSEQUENT PROCEDURES AFTER THE ALLEGED EVENT REPORTED ON THIS RECORD. A SYSTEM LOG REVIEW WAS PERFORMED, BUT NO ERRORS RELATED TO THIS EVENT WOULD EXIST IN THE LOGS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE BROKE OFF THE HARMONIC ACE SHEARS AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. ALTHOUGH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED, IT IS UNKNOWN WHAT CAUSED THE INSTRUMENT TO BREAK INSIDE OF THE PATIENT. IN ADDITION, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "233717669", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, A PIECE BROKE OFF OF THE HARMONIC ACE SHEARS AND FELL INSIDE THE PATIENT. THE PIECE WAS IMMEDIATELY REMOVED. THE INSTRUMENT WAS DISCARDED AND WILL NOT BE RETURNED. THE INSTRUMENT WAS REPLACED WITH A BACKUP HARMONIC ACE INSTRUMENT AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS DISSECTING WHEN THE INSTRUMENT BROKE. THE INSTRUMENT WAS IN USE FOR ABOUT AN HOUR AND DID NOT HAVE ANY CONTACT WITH OTHER INSTRUMENTS OR OTHER HARD MATERIALS. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE HARMONIC AVE INSTRUMENT WAS REMOVED DURING THE PROCEDURE WITH A STRAIGHTENED WRIST. NO X-RAYS OR ULTRASOUNDS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT DID NOT RETURN TO THE HOSPITAL WITH POST-OPERATIVE COMPLICATIONS. THERE IS NO VIDEO RECORDING AVAILABLE FOR REVIEW." } ], "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" } ] }