{ "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": "2955842-2020-10687", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200725", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200117", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20200725", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190823", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "788400", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200725", "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": "M90190823 0279", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200729", "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)210831(10)M90190823", "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": "07/26/2020;07/26/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "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": "20200725", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "67 KG", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200629", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10324219", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "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": "318858967", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "318858968", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS IN USE FOR ABOUT 10 MINUTES PRIOR TO THE BREAKAGE. ALL FRAGMENT(S) WERE RETRIEVED WITH FORCEPS. THE SURGEON WAS DISSECTING TISSUE WHEN THE ISSUE OCCURRED. THE SURGEON ALLEGED THAT THE HARMONIC ACE WAS NOT AS GOOD AS THE THIRD PARTY LAPAROSCOPIC HARMONIC INSTRUMENT. NO INFORMATION WAS PROVIDED PERTAINING TO THE TESTS/LABORATORY DATA SPECIFIC TO THE INCIDENT. 61 - ISI RECEIVED THE HARMONIC ACE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND WITH A BROKEN CURVED BLADE. A BROKEN PIECE, APPROXIMATELY 0.36\" X 0.10\" WAS NOT RETURNED. MATERIAL WAS MISSING. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY 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 (480275-08/M90190823 0279) WAS PERFORMED. THE INSTRUMENT WAS LAST USED ON (B)(6) 2020 ON SYSTEM SK3149. THIS IS A SINGLE-USE INSTRUMENT. PER REVIEW OF THE SUBMITTED IMAGE, THE TITANIUM WAS BROKEN OFF FROM THE INSTRUMENT. THE INSTRUMENT & ACCESSORY USER MANUAL STATES: \"AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE DEVICE IS ACTIVATED. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED MAY RESULT IN A CRACKED OR BROKEN BLADE, WHICH MAY BE IDENTIFIED BY A GENERATOR SOLID TONE OR AN INSTRUMENT ERROR. SCRATCHES ON THE BLADE TIP MAY LEAD TO PREMATURE BLADE FAILURE.\" BASED ON THE FAILURE ANALYSIS RESULTS, THE INITIAL MDR REPORT IS BEING RETRACTED AS THE DAMAGE TO THE INSTRUMENT WAS FOUND TO BE DUE TO MISHANDLING/MISUSE AND NOT DUE TO A MALFUNCTION OF THE UNIT." }, { "mdr_text_key": "336071126", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336071127", "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": "241925779", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSERT 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 REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE (480275-08/M90190823) ON THE REPORTED EVENT DATE OF (B)(6) 2020 FOR SYSTEM (B)(4) WAS PERFORMED. TWO HARMONIC ACE INSTRUMENTS WITH THE SAME MODEL AND LOT NUMBER WERE LOGGED FOR THIS CASE; HOWEVER, AS THE CUSTOMER DID NOT PROVIDE THE PRODUCT SEQUENCE NUMBER, THE INSTRUMENT THAT FAILED CANNOT BE CONFIRMED PER THE LOG. 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 AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, 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": "241925780", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND FRACTURED. THE FRAGMENT WAS EASILY RETRIEVED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 12 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS DISSECTING THE TISSUE WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE CUSTOMER CONFIRMED THE FRACTURED ENDS WERE COMPLETELY COINCIDENT. THERE WAS NO REPORT OF COLLISION WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE, AND THERE WAS NO RESISTANCE NOTED UPON REMOVAL THROUGH THE CANNULA. THE SURGEON BELIEVE THE BREAKAGE OCCURRED DUE TO THE QUALITY OF THE INSTRUMENT. NO SURGICAL PROCEDURE WAS REQUIRED AND POST-OPERATIVE TESTS WERE PERFORMED DUE TO THE EVENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS DUE TO RETAINING A FOREIGN OBJECT. NO VIDEO RECORDING OF THE PROCEDURE WAS AVAILABLE FOR REVIEW. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED." } ], "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": "08/24/2020;05/24/2023" } ] }