{ "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": "2955842-2021-10574", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210528", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210418", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20210528", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200528", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "800620", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210528", "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", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "M90200528 0101", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210521", "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)220531(10)M90200528", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Fracture", "Fracture" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/29/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20210528", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210429", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11904547", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210429", "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": "267743604", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A HARMONIC ACE FROM THE CUSTOMER AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS NOT CONFIRMED DURING FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT THAT WAS RETURNED DID NOT HAVE A BROKEN BLADE OR CLAMP ARM AT THE DISTAL END. THE INSTRUMENT WAS FOUND TO HAVE MECHANICAL INDENTATION DAMAGE TO THE BLADE. 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 TO OR AN ERROR. THE ROOT CAUSE OF MECHANICAL INDENTATIONS/BURRS INSTRUMENT BLADES IS TYPICALLY ATTRIBUTED TO MISUSE/MISHANDLING. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE ALLEGED COMPLAINT OF \"THE ULTRASONIC KNIFE HEAD SUDDENLY BROKE OFF\". THE CUSTOMER DID NOT PROVIDE THE PRODUCT'S SEQUENCE NUMBER OF THE REPORTED INSTRUMENT; THEREFORE, VERIFICATION OF THE PRODUCT AND EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED. A REVIEW OF THE INSTRUMENT LOG FOR THE RETURNED HARMONIC ACE (480275-08/M90200528 0101) WAS PERFORMED. THE INSTRUMENT WAS USED ON (B)(6) 2021 ON SYSTEM (B)(4). THE INSTRUMENT WAS NOT CONFIRMED TO BE USED ON THE PROVIDED EVENT DATE OF (B)(6) 2021. THIS IS A SINGLE-USE INSTRUMENT. THE CLINICAL SALES REPRESENTATIVE (CSR) WAS CONTACTED TO VERIFY IF THE CORRECT INSTRUMENT WAS RETURNED. THE LOT NUMBER OF THE REPORTED INSTRUMENT IS M90200323 AND THE LOT NUMBER OF THE RETURNED INSTRUMENT IS M90200528. UPON FAILURE ANALYSIS, THE ALLEGED COMPLAINT WAS NOT CONFIRMED AS THE HARMONIC ACE INSTRUMENT DID NOT HAVE A BROKEN BLADE. THE CSR REPORTED HAT THE AFTER THE PROCEDURE, THE CUSTOMER REPROCESSED THE REPORTED INSTRUMENT AS IT WAS USED ON THE PATIENT. THE INSTRUMENT WAS GIVEN TO THE CHARGE NURSE, WHO RETRIEVED THE BOX IN THE HOSPITAL STORAGE ROOM FOR PRODUCT RETURN. THE LOT NUMBER WAS DOCUMENTED BY THE CSR FOR COMPLAINT INTAKE. PER FOLLOW-UP WITH THE CSR, THE RETURNED PRODUCT COULD NOT BE CONFIRMED TO BE THE INSTRUMENT PERTAINING TO THIS COMPLAINT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT BROKE OFF OF THE HARMONIC ACE INSTRUMENT AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE CUSTOMER PROVIDED IMAGES OF THE HARMONIC ACE WITH A MISSING BLADE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. ALTHOUGH THERE WAS NO PATIENT HARM REPORTED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "267743605", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MASTER KNIFE WAS CUTTING THE LIVER, AND THE ULTRASONIC KNIFE HEAD SUDDENLY BROKE OFF WITHOUT ANY HINT. FORTUNATELY, THE BROKEN KNIFE HEAD WAS PICKED OUT. THE FRAGMENT WAS RETRIEVED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR APPROXIMATELY ONE HOUR PRIOR TO THE BREAKAGE. THE SURGEON HAD NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON HAD NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM PRIOR TO THE BREAKAGE. THERE WAS NO REPORT OF COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. ALL FRAGMENT(S) WERE RETRIEVED WITH THE ENDOSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. NO SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. NO INFORMATION WAS PROVIDED PERTAINING TO IF THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WAS PROVIDED PERTAINING TO THE PATIENT MEDICAL HISTORY, PRE-EXISTING MEDICAL CONDITIONS, OR TESTS/LABORATORY DATA SPECIFIC TO THE INCIDENT." }, { "mdr_text_key": "336070868", "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\"." }, { "mdr_text_key": "336070869", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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" } ] }