{ "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": "2955842-2023-21016", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20231213", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20230428", "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": "NIELSON", "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": "20231213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220317", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1824565", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231213", "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": "400272-03", "catalog_number": "400272", "lot_number": "L90220317", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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)L90220317", "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": "12/17/2023", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20231213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231115", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18320182", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231115", "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": "330397719", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED FOR RETURN OF THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "330397720", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOTICED TO BE BROKEN. THE FRACTURED PART FELL INSIDE THE PATIENT BUT WAS RETRIEVED AND REMOVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY." }, { "mdr_text_key": "339679882", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE ROUGHLY 0.072¿ FROM THE BASE. THE BROKEN PIECE WAS RETURNED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI FOLLOWED UP WITH THE SITE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE ISSUE HAPPENED AS THE SURGEON WAS CUTTING. THE SURGEON BELIEVES WHAT CAUSED THE ISSUE IS A QUALITY PROBLEM. THE ISSUE WITH THE INSTRUMENT OCCURRED ABOUT 3 MINUTES AFTER THE PROCEDURE STARTED. THE SURGEON NOTICED FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE AND THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE UPON THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED THROUGH THE SCREEN. NO ADDITIONAL SURGICAL PROCEDURES WERE DONE TO REMOVE THE FRAGMENT. AN ULTRASOUND WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "339679883", "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": "01/08/2024" } ] }