{ "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": "2955842-2020-11046", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201006", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20200910", "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": "20201006", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190129", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1099069", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201006", "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": "400272-03", "catalog_number": "400272", "lot_number": "M10181203", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201014", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111083", "udi_public": "(01)10886874111083(10)M10181203", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/15/2020;09/11/2020", "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": "20201006", "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": "20200911", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10639397", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200911", "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": "321409060", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE HARMONIC INSERT WAS FOUND TO HAVE DAMAGE TO THE CLAMP ARM. A PIECE OF THE TEFLON PAD OF THE CLAMP ARM WAS DETACHED AND THE DETACHED MATERIAL WAS RETURNED WITH THE INSERT. THE CLAMP ARM DAMAGE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE HARMONIC INSERT WAS FOUND TO HAVE A DAMAGED BLADE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE." }, { "mdr_text_key": "321409061", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335839870", "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": "335839871", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "219198552", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE PRODUCT 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: ALTHOUGH THERE WAS NO REPORT OF PATIENT INJURY, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "219198553", "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, FRAGMENTS OF THE HARMONIC ACE TISSUE PAD WERE FOUND TO BE STUCK TO THE PATIENT'S TISSUE AND WERE RETRIEVED FROM THE BODY CAVITY. IT WAS REPORTED THAT AFTER THAT, THE PRODUCT WAS NOT FOUND TO HAVE FUNCTIONAL PROBLEMS SO THE CUSTOMER CONTINUED USING IT. 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 PRODUCT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED. ALL FRAGMENTS WERE REMOVED USING LAPAROSCOPIC FORCEPS AND NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENTS. AN X-RAY EXAMINATION WAS PERFORMED AFTER THE OPERATION TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON STATED THAT THE REPORTED ISSUE RARELY OCCURS WITH OTHER COMPANIES' PRODUCTS WHEN NOT GRASPING TISSUE AND STATED THAT THEY DO NOT KNOW WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE PRODUCT BROKE AS THEY USED THE PRODUCT WITHOUT NOTICING THAT IT WAS DAMAGED. IT IS UNKNOWN WHETHER THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE, AND WHETHER THE FRAGMENTS FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE, BUT IT COULD NOT BE CONFIRMED WHETHER THE SURGICAL STAFF FELT ANY RESISTANCE UPON REMOVAL OF THE PRODUCT THROUGH THE CANNULA AT THAT TIME. IT COULD ALSO NOT BE CONFIRMED WHETHER THE SURGICAL STAFF FELT ANY RESISTANCE UPON REMOVAL OF THE PRODUCT THROUGH THE CANNULA UPON FINAL REMOVAL OF THE PRODUCT AND WHETHER THE SURGICAL STAFF NOTICED ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE PRODUCT AFTER THE EVENT OCCURRED AND AFTER REMOVING THE FRAGMENTS, THE CUSTOMER CONTINUED USING THE PRODUCT, AND NO ERROR, OR ABNORMALITY OCCURRED DURING ITS USE. NO INJURY OCCURRED TO THE PATIENT. THE CUSTOMER WAS UNWILLING TO PROVIDE THE CUSTOMER DEMOGRAPHIC INFORMATION, NOR INFORMATION ABOUT THE CUSTOMER'S MEDICAL HISTORY." } ], "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": "11/09/2020;05/24/2023" } ] }