{ "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": "2955842-2021-10789", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210714", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20210714", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200910", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1065942", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210714", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210616", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "M90200914 0001", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210629", "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)220930(10)M90200914", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20210714", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210616", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12165607", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210616", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "335722466", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1. B1 UPDATED FROM \"ADVERSE EVENT\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\"." }, { "mdr_text_key": "335722467", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "261441228", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND DAMAGE ON THE TEFLON PAD AT THE CLAMP ARM. A PIECE OF THE TEFLON PAD MEASURING APPROXIMATELY 0.100\" X 0.079\" WAS NOT RETURNED WITH THE INSTRUMENT. THE KNOWN CAUSE OF THIS ISSUE IS ATTRIBUTED TO MISHANDLING AND MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE HARMONIC ACE INSTRUMENT SHOWS A SLIGHTLY DISLODGED TEFLON PAD FROM THE CLAMP ARM TOWARDS THE PROXIMAL END OF THE GRIPS. COMPARISON FROM A REFERENCE HARMONIC ACE INSTRUMENT INDICATES A LIKELY DISPLACEMENT ON THE DISTAL END. DISLODGED TEFLON PADS ARE TYPICALLY ATTRIBUTED TO USER MISHANDLING, SUCH AS IMPROPER CLEANING, COLLISIONS, OR GRASPING ONTO HARD OBJECTS (CLIPS, STAPLES, CARTILAGE, BONE, ETC.) A SYSTEM LOG REVIEW CONFIRMED THAT ON THE EVENT DATE OF (B)(6) 2021 A PROCEDURE WAS PERFORMED AND USE OF THE HARMONIC ACE INSTRUMENT WITH LOT# M90200914 / SEQUENCE 0001 WAS CONFIRMED. THE INSTRUMENT IS SINGLE USE THEREFORE NO SUBSEQUENT USE WAS RECORDED. 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 COMPLAINT INFORMATION AND THE ADDITIONAL INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATION AND FAE IMAGE ANALYSIS, THE HARMONIC ACE INSTRUMENT TEFLON PAD TIP BROKE. A PIECE WAS FOUND TO BE MISSING AND COULD NOT BE LOCATED. THE FRAGMENT FROM THE TEFLON PAD POSSIBLY FELL INSIDE THE PATIENT. THE LOCATION OF THE MISSING FRAGMENT REMAINS UNKNOWN. FAILURE ANALYSIS CONFIRMED THE ISSUE AND THE ROOT CAUSE WAS ATTRIBUTED TO USER MISHANDLING OR MISUSE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT THAT WAS REPORTED, THE MISSING FRAGMENT WAS POSSIBLY RETAINED INSIDE THE PATIENT AND THE EVENT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "261441229", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT TEFLON PAD TIP BROKE AND A PIECE WAS FOUND TO BE MISSING. THE INSTRUMENT WAS REMOVED AND USE WAS DISCONTINUED. THE CUSTOMER COMPLETED THE PROCEDURE WITH NO OTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND NO ISSUE. THE INSTRUMENT INITIALLY WORKED; HOWEVER, AT AN UNSPECIFIED TIME ALLEGEDLY BROKE AND A FRAGMENT FROM THE BROKEN TEFLON PAD POSSIBLY FELL INSIDE THE PATIENT. DURING INTRAOPERATIVE USE, THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT. THE CUSTOMER COULD NOT CONFIRM THE MOMENT WHEN THE INSTRUMENT BROKE, NOR COULD THEY ASCERTAIN IF A BROKEN PIECE ACTUALLY FELL INSIDE THE PATIENT. THE SURGEON REVIEWED THE PROCEDURE VIDEO, AND INSPECTED THE PATIENT'S BODY AND FOUND NO RETAINED FRAGMENT. NO ADDITIONAL SURGICAL INTERVENTION WAS CONDUCTED. FOLLOW UP INFORMATION CONFIRMED NO KNOWN IMPACT OR PATIENT CONSEQUENCE. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AS OF THE DATE OF THIS REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/24/2023" } ] }