{ "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": "2955842-2021-10507", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210514", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210412", "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": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20210514", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20201029", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "721811", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210514", "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": "M90201101 0260", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210517", "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)221031(10)M90201101", "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": "05/18/2021;04/16/2021", "mfr_report_type": "", "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": "20210514", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "67 YR", "patient_sex": "Female", "patient_weight": "56 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210416", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11824724", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210416", "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": "267902831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT YET RECEIVED THE HARMONIC ACE INSTRUMENT FOR ANALYSIS TO BE COMPLETED. 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 RECEIVED FOR TESTING AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THE FULL LOT NUMBER OF THE INSTRUMENT WAS NOT PROVIDED. THEREFORE, AN INSTRUMENT LOG REVIEW WAS UNABLE TO BE PERFORMED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED 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. WHILE THERE WAS NO HARM OR INJURY TO PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "267902832", "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 BLADE OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER RETRIEVED THE WHITE POWDER FRAGMENTS BY SUCTION. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 5 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS DISSECTING TISSUES WHEN THE DEVICE FRAGMENTS FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA OR TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR VIDEO RECORDING OF THE PROCEDURE WERE AVAILABLE FOR RETURN. THE CUSTOMER WAS UNABLE TO DISCLOSE PATIENT-RELATED INFORMATION." }, { "mdr_text_key": "323925339", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED/UPDATED INFORMATION CAN BE FOUND IN D4 - THE BATCH SEQUENCE OF THE LOT NUMBER WAS OBTAINED THROUGH THE PRODUCT RETURN. D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS TESTED FOR ENERGY DELIVERY AND PASSED. UPON VISUAL INSPECTION, THE TEFLON PAD AND THE CURVED BLADE WAS NOT OBSERVED TO BE BROKEN AND THERE WAS NO MISSING MATERIAL OBSERVED. THERE WAS NO PROBLEM DETECTED. THERE WERE ADDITIONAL OBSERVATION(S) NOT REPORTED BY THE SITE: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. MECHANICAL INDENTATIONS WERE OBSERVED AT THE TIP OF THE HARMONIC ACE BLADE. THE INSTRUMENT WAS FOUND TO HAVE TEFLON PAD DAMAGE. THE TEFLON PAD APPEARED TO BE PARTIALLY DISLODGED TOWARDS THE PROXIMAL END OF THE GRIPS. NO MISSING MATERIAL WAS OBSERVED. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. A REVIEW OF THE DEVICE LOGS FOR THE HARMONIC ACE (PART# 480275-08 / LOT/SERIAL# (B)(6)) 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)(6). 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." }, { "mdr_text_key": "336652846", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336652847", "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\"." } ], "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": "06/12/2021;05/24/2023" } ] }