{ "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": "2955842-2021-10466", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210430", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210330", "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": "20210430", "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": "647534", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210430", "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 0156", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210513", "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": "05/14/2021;04/05/2021", "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": "20210430", "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": "20210405", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11757591", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210405", "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": "324924542", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324924543", "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 INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.18¿ FROM THE BASE AND THE BROKEN PIECE WAS RETURNED. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE ROOT CAUSE OF BROKEN INSTRUMENT BLADES IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. THERE WAS AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. THE BLADE EXHIBITED MECHANICAL INDENTATIONS. THE ROOT CAUSE OF MECHANICAL INDENTATIONS/BURRS INSTRUMENT BLADES 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": "267890022", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT YET RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED FOLLOWING THE COMPLETION OF FAILURE ANALYSIS AND IF ADDITIONAL INFORMATION IS RECEIVED. THE FULL INSTRUMENT LOT NUMBER WAS NOT PROVIDED. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO ADDITIONAL LOG REVIEW WAS PERFORMED AS THIS TYPE OF FAILURE WOULD NOT RESULT IN AN ERROR IN THE LOGS. 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: THE COMPLAINT ALLEGED THE HARMONIC ACE INSTRUMENT HAD A MELTED TEFLON PAD WITH FRAGMENTS FALLING INSIDE THE PATIENT. UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "267890023", "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 DURING THE SAME SURGICAL PROCEDURE. 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 FRAGMENT AND CONFIRMED BY VISUAL INSPECTION THAT THERE WERE NO OTHER PIECES. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THE INSTRUMENT WAS IN USE FOR ABOUT 5 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS DISSECTING TISSUE WHEN THE DEVICE FRAGMENT 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 AND DID NOT NOTE ANY OTHER DAMAGE 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": "335712769", "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": "335712770", "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": "06/08/2021;05/24/2023" } ] }