{ "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": "2955842-2021-11551", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211119", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20211026", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20211120", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20191017", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1743106", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211119", "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": "M90191020 0392", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211111", "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)M90191020", "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": "10/26/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20211119", "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": "20211026", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12849402", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211026", "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": "336424251", "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 ADVERSE EVENT, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1. B1 UPDATED FROM \"ADVERSE EVENT\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\"." }, { "mdr_text_key": "336424252", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "283326600", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED AN IMAGE OF THE HARMONIC ACE INSTRUMENT AND IT WAS REVIEWED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). BY THE IMAGE ALONE, THE FAE COULD NOT DETERMINE IF THERE WAS A MISSING FRAGMENT OF THE TEFLON PAD FROM THE PROVIDED IMAGE. THE RESOLUTION WAS TOO LOW TO DETERMINE IF THE DARK SPOT ON THE DISTAL EDGE WAS A MISSING FRAGMENT OR BIODEBRIS. ISI ALSO RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS EVENT AND COMPLETED THE FAILURE ANALYSIS INVESTIGATION. FAILURE ANALYSIS TESTING FOUND THAT THE CUSTOMER-REPORTED COMPLAINT OF THE PAD MISSING FROM THE HARMONIC ACE INSTRUMENT COULD BE CONFIRMED. THE TEFLON PAD OF THE CLAMP ARM HAD DAMAGE AND A PIECE OF MATERIAL APPROXIMATELY 0.044\" X 0.018\" IN SIZE WAS MISSING. THE ROOT CAUSE OF THIS FAILURE WAS DETERMINED TO BE DUE TO USER MISHANDLING/MISUSE. A REVIEW OF THE DEVICE LOGS FOR THE HARMONIC ACE (PART# 480275-08 / LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE HARMONIC ACE WAS LAST USED ON (B)(6) 2021 VIA SYSTEM SERIAL# (B)(4). THERE WERE 0 USES REMAINING AFTER THIS LAST USAGE. THIS DEVICE IS A SINGLE-USE INSTRUMENT AND THEREFORE ONLY HAS ONE USE ALLOTTED TO IT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. A REVIEW OF THE SITE'S COMPLAINT HISTORY WAS PERFORMED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED FOR THIS PRODUCT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A MISSING FRAGMENT. THE MISSING FRAGMENT WAS UNABLE TO BE FOUND. IT WAS UNKNOWN IF THE FRAGMENT FELL INSIDE THE PATIENT'S ANATOMY AND WAS RETAINED. THE INSTRUMENT WAS RETURNED AND FAILURE ANALYSIS TESTING DETERMINED THAT THE MISSING PIECE RESULTED FROM MISHANDLING/MISUSE. AS OF THE DATE OF THIS REPORT, THE LOCATION OF THE MISSING FRAGMENT REMAINS UNKNOWN." }, { "mdr_text_key": "283326601", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD A MISSING TISSUE PAD. THE CUSTOMER DID NOT KNOW IF THE MISSING PART FELL INTO THE PATIENT BODY. THE CUSTOMER USED A BACKUP INSTRUMENT OF THE SAME KIND TO CONTINUE. THE PROCEDURE CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGICAL NURSE AND OBTAINED ADDITIONAL INFORMATION ON 28-OCT-2021. THE CUSTOMER REPORTED THAT THE MISSING FRAGMENT FROM THE HARMONIC ACE INSTRUMENT COULD NOT BE FOUND BECAUSE IT WAS TOO SMALL. IT WAS UNKNOWN IF THE FRAGMENT FELL INSIDE THE PATIENT, THERE WAS NO FRAGMENT RETRIEVED FROM THE PATIENT'S ANATOMY AND THE LOCATION OF THE FRAGMENT REMAINS UNKNOWN. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRA SOUND PERFORMED. IT WAS UNKNOWN WHEN THE INSTRUMENT BREAKAGE OCCURRED; IT COULD HAVE HAPPENED DURING USAGE OR CLEANING. THE INSTRUMENT WAS IN USE FOR 2-3 HOURS PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITY WAS OBSERVED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER STOPPED USING THE INSTRUMENT AFTER THE ISSUE WAS IDENTIFIED. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE ISSUE BEING IDENTIFIED, AND IT WAS UNKNOWN IF THE WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." } ], "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": "05/24/2023" } ] }