{ "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": "2955842-2021-11216", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210929", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210901", "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": "WANG", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20210929", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20210119", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1446419", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210929", "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": "M90210119 0006", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211026", "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)230131(10)M90210119", "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": "10/27/2021;09/03/2021", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20210929", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "69 YR", "patient_sex": "Male", "patient_weight": "80 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210903", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12545262", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210903", "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": "327251608", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D11-INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC ACE ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF TEFLON PAD DAMAGE TO BE RELATED THE REPORTED COMPLAINT. THE TEFLON PAD ON THE CLAMP ARM WAS COMPLETELY DETACHED FROM THE INSTRUMENT. HOWEVER, THE TEFLON PAD WAS RETURNED WITH THE INSTRUMENT. NO PIECES WERE MISSING. THE BLADE WAS INSPECTED AND NO DAMAGE WAS FOUND. THE ROOT CAUSE FOR THE TEFLON PAD DAMAGE IS ATTRIBUTED TO MISHANDLING/MISUSE." }, { "mdr_text_key": "327251609", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "273771294", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE HARMONIC ACE CURVED SHEARS BE RETURNED FOR EVALUATION, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED. 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 AND/OR THIS EVENT. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE INSTRUMENT (PART# 480275-08 LOT# M90210119 0006) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE HARMONIC ACE WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK0207. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: ALL FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENTS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR." }, { "mdr_text_key": "273771295", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGOSTOMY SURGICAL PROCEDURE, AN UNSPECIFIED PART OF THE HARMONIC ACE CURVED SHEARS FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. A SIMILAR BACKUP INSTRUMENT WAS USED TO PROCEED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. PER SUBSEQUENT FOLLOW-UP RECEIVED ON 07 SEPTEMBER 2021, THE SITE CONFIRMED THAT PRIOR TO THE START OF THE PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS INSPECTED AND NO ISSUES WERE OBSERVED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30 MINUTES WHEN THE REPORTED ISSUE OCCURRED. THE USER WAS APPLYING ENERGY WHEN IT WAS OBSERVED THAT A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE REPORTER INDICATED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER DURING PROCEDURE. AFTER THE ISSUE OCCURRED, THE OPERATING ROOM STAFF REMOVED THE INSTRUMENT. THE OPERATING ROOM STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND THERE WAS NO DAMAGE FOUND TO THE CANNULA OR TO THE INSTRUMENT. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED ISSUE." }, { "mdr_text_key": "335535674", "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": "335535695", "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": "11/21/2021;05/24/2023" } ] }