{ "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": "2955842-2021-10908", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210808", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20210808", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1189362", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210808", "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": "M90201208 0166", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210730", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)221231(10)M90201208", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20210808", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20210711", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12292274", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210711", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "265587788", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE PATIENT'S BLEEDING IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS NOT CONFIRMED DURING FAILURE ANALYSIS. THE INSTRUMENT WAS CONNECTED TO THE IN-HOUSE HARMONIC ACE GENERATOR AND PASSED RECOGNITION. 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 CLAMP OPENED AND CLOSED PROPERLY. ENERGY DELIVERY TEST WAS PERFORMED AND PASSED MULTIPLE TIMES. NO ERROR MESSAGE WAS OBSERVED DURING IN-HOUSE TESTING. THERE WAS NO TROUBLE FOUND IN RELATION TO THE CUSTOMER'S ALLEGATION. ADDITIONAL FINDINGS WERE OBSERVED DURING FAILURE ANALYSIS BUT WERE NOT REPORTED BY THE CUSTOMER. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. THE INSTRUMENT'S BLADE EXHIBITED MECHANICAL INDENTATIONS. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISUSE/MISHANDLING. A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE (480275-08/M90201208 0166) WAS PERFORMED. THE INSTRUMENT WAS USED ON 02-JUL-2021 ON SYSTEM SK2922. TWO IMAGES OF THE HARMONIC ACE INSTRUMENT WERE PROVIDED BY THE CUSTOMER. THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED UPON REVIEW OF THE PROVIDED IMAGE. THE IMAGES SHOW THE HARMONIC ACE WITH NO MISSING FRAGMENTS. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: THE DA VINCI 8 MM HARMONIC ACE CURVED SHEARS IS A SINGLE-USE, STERILE INSTRUMENT USED TO DELIVER ULTRASONIC ENERGY TO ENABLE TRANSECTION AND COAGULATION OF TISSUE. IT IS DESIGNED TO BE USED IN CONJUNCTION WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ETHICON ENDO-SURGERY GENERATOR AND HAND PIECE. IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT REPORTEDLY SUFFERED FROM \"A LOT OF BLEEDING.\" PER FOLLOW-UP, THE BLEEDING CAME FROM THE LIVER TISSUE AND THERE WAS APPROXIMATELY LESS THAN 800ML OF BLOOD LOSS. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE BLEEDING. THE CUSTOMER HAD TO ADMINISTER OR TRANSFUSE 400ML OF BLOOD. THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE NO OTHER ISSUES REPORTED. THE HARMONIC ACE INSTRUMENT WAS EVALUATED BY THE FAILURE ANALYSIS TEAM AND THE CUSTOMER REPORTED COMPLAINT WAS NOT CONFIRMED AS THE INSTRUMENT PERFORMED AS INTENDED DURING INSPECTION. THE INSTRUMENT WAS FOUND TO HAVE MECHANICAL INDENTATIONS ON THE BLADE, AND THE KNOWN COMMON CAUSE OF THIS FAILURE MODE IS MISHANDLING/MISUSE. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "265587789", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM \"A LOT OF BLEEDING.\" THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. ON 15-JULY-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) CLARIFIED THAT THE PROMPT INDICATING EXCESS PRESSURE ON THE HARMONIC ACE INSTRUMENT DISPLAYED AFTER ONE HOUR, DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE BLEEDING WAS COMING FROM THE LIVER TISSUE. THERE WAS APPROXIMATELY LESS THAN 800ML OF BLOOD LOSS. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE BLEEDING. THE CUSTOMER HAD TO ADMINISTER OR TRANSFUSE 400ML OF BLOOD. NO INFORMATION WAS PROVIDED REGARDING IF THE PATIENT HAD RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }