{ "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": "2955842-2020-11369", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201217", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20201102", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20201217", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200130", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1493584", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201217", "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": "M90200119 0339", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201230", "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)220131(10)M90200204", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/31/2020;11/24/2020", "mfr_report_type": "", "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": "20201217", "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", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201124", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11025978", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201124", "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": "323255602", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN FIELDS: D4, D10, G4, G7, H2, H3, H6, H8, AND H10/H11. 61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE TEFLON PAD DAMAGE. A PIECE MEASURING APPROXIMATELY 0.020\" X 0.087\" WAS FOUND TORN FROM THE TEFLON PAD AT THE DISTAL END AND THE TORN PIECE WAS RETURNED WITH THE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE MISHANDLING. THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.118¿ FROM THE BASE, AND 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 ROOT CAUSE OF THIS FAILURE IS FATIGUE FAILURE DUE TO MISHANDLING/MISUSE. A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS EVENT CONFIRMED THAT THE INSTRUMENT WAS USED ON 2-NOV-2020 ON SYSTEM SK2294. THE HARMONIC ACE INSTRUMENT IS A SINGLE USE INSTRUMENT AND WAS NOT USED DURING SUBSEQUENT PROCEDURES." }, { "mdr_text_key": "323255603", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335841053", "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": "335841054", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "222409154", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT. IF THE PRODUCT IS RECEIVED, OR IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT ,AND/OR THIS EVENT. NO IMAGE, OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THE DA VINCI 8 MM HARMONIC ACE CURVED SHEARS IS A SINGLE-USE, STERILE INSTRUMENT USED TO DELIVER ULTRASONIC ENERGY TO ENABLE TRANSECTION AND COAGULATION OF TISSUE. IT IS DESIGNED TO BE USED IN CONJUNCTION WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ETHICON ENDO-SURGERY GENERATOR AND HAND PIECE. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE: DURING A DA VINCI SURGICAL PROCEDURE, A FRAGMENT FROM THE HARMONIC ACE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED. ALTHOUGH THERE WAS NO REPORT OF PATIENT INJURY, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "222409155", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT TISSUE PAD WAS FOUND TO BE MISSING IMMEDIATELY AFTER SURGERY. THE CUSTOMER STATED THAT THE INSTRUMENT'S BLADE BROKE DURING CLEANING AND A FRAGMENT FELL INTO THE PATIENT. THE CUSTOMER CONFIRMED THAT THE FRAGMENT WAS SUCCESSFULLY RETRIEVED AND THAT THERE WERE NO REMAINING FRAGMENTS INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT AND A POST-OPERATIVE TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR 5 MINUTES PRIOR TO THE ISSUE AND THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL AND IT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA, AND DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. NO INJURY OCCURRED TO THE PATIENT." } ], "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": "01/22/2021;05/24/2023" } ] }