{ "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": "2955842-2020-10795", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200826", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200720", "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": [ "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": "20200826", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200227", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "919209", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200826", "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": "DA VINCI", "lot_number": "M90200303", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200901", "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)220228(10)M90200303", "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": "08/26/2020;08/26/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250730", "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": "20200826", "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": "20200728", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10454759", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200728", "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": "319476712", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "319476713", "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 PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO THE REPORTED EVENT. 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. BROKEN PIECE, APPROXIMATELY 0.18\" X 0.10\" WAS RETURNED. NO MATERIAL APPEARED TO BE MISSING AS THE BROKEN ASSEMBLY WAS PIECED BACK TOGETHER. 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 (480275-08/M90200318 0099) WAS PERFORMED. THE INSTRUMENT WAS LAST USED ON 20-JUL-2020 ON SYSTEM SK2922. THIS IS A SINGLE-USE INSTRUMENT. 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": "334962295", "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": "242646460", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE 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. A REVIEW OF THE INSTRUMENT LOG FOR (B)(4) ON 07/22/2020 WAS PERFORMED. THE LOGS SHOWED TWO HARMONIC ACE INSTRUMENTS WITH THE SAME LOT NUMBER. SINCE THE PRODUCT SEQUENCE NUMBER WAS NOT PROVIDED, THE INSTRUMENT RELATED TO THE COMPLAINT CANNOT BE VERIFIED PER INSTRUMENT LOG AT THIS TIME. THE CUSTOMER PROVIDED AN IMAGE OF THE HARMONIC ACE, AND UPON REVIEW, THE TITANIUM-CURVED BLADE OF THE HARMONIC ACE INSERT WAS MISSING. INTUITIVE SURGICAL RECEIVED A VIDEO CLIP OF A DA VINCI-ASSISTED SURGICAL PROCEDURE. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY A CLINICAL DEVELOPMENT ENGINEER (CDE). IT WAS NOTED THAT THE CUSTOMER WAS USING A FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO GRASP TISSUE AND ENERGY WAS APPLIED WITH THE HARMONIC ACE INSTRUMENT ON THE TENSIONED TISSUE. AS THE HARMONIC ACE WAS PULLING UP ON THE TISSUE, THE BLADE BROKE OFF AND FELL INTO THE PATIENT. NO CONTACT WAS OBSERVED BETWEEN THE HARMONIC ACE AND THE FENESTRATED BIPOLAR FORCEPS. 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": "242646461", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE \"ULTRASONIC NEEDLE\", OR BLADE, OF THE HARMONIC ACE BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE SITE IS UNABLE TO RELEASE PATIENT INFORMATION RELATED TO THIS INCIDENT. 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 ONE HOUR AND 34 MINUTES PRIOR TO THE BREAKAGE. ALL FRAGMENT(S) WERE RETRIEVED WITH OTHER UNSPECIFIED INSTRUMENTS DURING THE SAME PROCEDURE. NO SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON WAS USING THE INSTRUMENT TO DISSECT TISSUE AND DID NOT HAVE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON HAD NO ISSUES WITH REMOVING THE INSTRUMENT PRIOR TO THE BREAKAGE. THERE WAS NO REPORT OF COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. NO INFORMATION WAS PROVIDED REGARDING IF THE PATIENT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WAS PROVIDED PERTAINING TO PATIENT DEMOGRAPHICS OR TESTS/LABORATORY DATA SPECIFIC TO THE INCIDENT." } ], "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": "09/17/2020;05/24/2023" } ] }