{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2020-10743", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20200813", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200629", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "KR", "manufacturer_contact_area_code": "", "date_added": "20200813", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "866198", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200813", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "N10200121-0061", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200803", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00886874112731", "udi_public": "(01)00886874112731(17)220228(10)M90200301", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200813", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "28 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20200714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10404960", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200714", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "210180080", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED ISSUE THAT THE INSTRUMENT HAD BROKEN METAL AROUND THE INSTRUMENT¿S WRIST AREA. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.157¿ FROM THE BASE. 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 THIS FAILURE IS FATIGUE FAILURE DUE TO MISHANDLING/MISUSE. A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA ONCE THE FAILURE ANALYSIS INVESTIGATION HAS BEEN COMPLETED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THE INSTRUMENT LOGS CONFIRM THAT HARMONIC ACE INSTRUMENT (PART #480275-08; LOT #M90200301-0087) WAS USED DURING THE CASE ON (B)(6) 2020 USING SYSTEM (B)(4). THIS IS A SINGLE-USE INSTRUMENT. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: POTTS SCISSORS (PART #470001-09; LOT #N10200121-0061) AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. NO IMAGES OR VIDEO CLIPS FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. AS OF 07-AUG-2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, IT WAS ALLEGED THAT THE SURGEON HAD GRASPED UNSPECIFIED TISSUE WITH A HARMONIC ACE INSTRUMENT AND WAS NOT AWARE THAT THE INSTRUMENT HAD A BROKEN METAL PIECE. IT WAS NOTED THAT THERE WAS \"EXCESSIVE BLEEDING\" AND THE SURGICAL STAFF HAD DIFFICULTY CONTROLLING THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE SURGEON BELIEVES THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. ALTHOUGH IT WAS NOTED THAT THE AMOUNT OF BLEEDING WAS NOT HIGH AND THE SURGEON WAS ABLE TO CONTROL THE BLEEDING WITH ANOTHER INSTRUMENT, THE BLOOD LOSS VOLUME IS UNKNOWN. IN ADDITION, THE CAUSE OF THE BLEED AND CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE INFORMATION FOR THE REMAINING PATIENT-RELATED FIELDS IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, OR NOT PROVIDED. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. THE INFORMATION FOR FIELDS IN INITIAL REPORTER IS NOT AVAILABLE." }, { "mdr_text_key": "210180081", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE SURGEON HAD GRASPED UNSPECIFIED TISSUE WITH A HARMONIC ACE INSTRUMENT AND WAS NOT AWARE THAT THE INSTRUMENT HAD A BROKEN METAL PIECE. IT WAS ALSO NOTED THAT THERE WAS \"EXCESSIVE BLEEDING\" AND THE SURGICAL STAFF HAD DIFFICULTY CONTROLLING THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE SURGEON BELIEVES THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BLEEDING AND THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. PER THE INITIAL REPORTER, THE PATIENT'S CURRENT STATUS WAS \"RECOVERED.\" ON 10-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THE CUSTOMER COULD NOT RECALL WHAT SPECIFIC TISSUE WAS INVOLVED WITH THE \"EXCESSIVE BLEEDING.\" AFTER A TISSUE INCISION WAS MADE USING THE HARMONIC ACE INSTRUMENT, THE SURGEON ATTEMPTED TO USE THE COAGULATION FUNCTION. AT THAT TIME, THE CUSTOMER CLAIMED THAT THE INSTRUMENT DID NOT WORK AND BLEEDING OCCURRED. THE SURGEON WAS ABLE TO ACHIEVE HEMOSTASIS BY USING ANOTHER MONOPOLAR OR BIPOLAR INSTRUMENT. THE CUSTOMER COULD NOT RECALL THE ESTIMATED BLOOD LOSS VOLUME. HOWEVER, IT WAS NOTED THAT THE BLEEDING WAS NOT VERY HIGH AND NO BLOOD TRANSFUSIONS WERE ADMINISTERED. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE PATIENT HAS RECOVERED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }