{ "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": "2955842-2021-10325", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210327", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210302", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHARMACIST", "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": "FR", "manufacturer_contact_area_code": "408", "date_added": "20210327", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20191024", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "476033", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210327", "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": "M90191028 0117", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210401", "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)211031(10)M90191028", "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": "04/02/2021;03/02/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20210327", "sequence_number_treatment": [ "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": "20210302", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11579988", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210302", "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": "245779650", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. VERIFICATION OF THE EVENT DETAILS VIA SYSTEM LOGS CANNOT BE PERFORMED AT THIS TIME BECAUSE THERE IS INSUFFICIENT INSTRUMENT INFORMATION. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS DAMAGED AND NON-FUNCTIONAL AFTER ONE HOUR OF USE. THERE WAS REPORTEDLY ¿DEBRIS¿ THAT FELL INSIDE THE PATIENT AS A RESULT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. IN ADDITION,AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "245779651", "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 HARMONIC ACE INSTRUMENT WAS DAMAGED AND NON-FUNCTIONAL AFTER ONE HOUR OF USE. THERE WAS ¿DEBRIS¿ LEFT IN THE PATIENT. THE ¿DEBRIS¿ WAS RETRIEVED IN THE SAME PROCEDURE AND THE HARMONIC ACE WAS REMOVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT." }, { "mdr_text_key": "336744975", "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": "336744976", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324685840", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324685841", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE TEFLON PAD DAMAGE. THE TEFLON PAD APPEARED TO BE MELTED AND COMPLETELY DISLODGED FROM THE CLAMP ARM. THE DISLODGED TEFLON PAD WAS RETURNED AND NO MATERIAL WAS MISSING. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING. A REVIEW OF THE INSTRUMENT LOG FOR THE INSTRUMENT (PN: 480275-08/LOT#: M90191028 0117) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK2447. THIS IS A SINGLE USE INSTRUMENT." } ], "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": "04/28/2021;05/24/2023" } ] }