{ "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": "2955842-2021-10922", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210810", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20210521", "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": "20210810", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1197478", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210810", "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": "M90201122 0154", "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)221130(10)M90201122", "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": "20250728", "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": "20210810", "sequence_number_treatment": [ "" ], "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": "12305199", "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": "265988065", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED THE CAUSE OF THE INTRA-OPERATIVE BLEEDING IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE A CRACKED BLADE. AS A RESULT, AN ERROR MESSAGE WAS OBSERVED WHEN THE INSTRUMENT WAS CONNECTED TO THE HARMONIC ACE GENERATOR. 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 IS TYPICALLY ATTRIBUTED TO MISUSE/MISHANDLING. ADDITIONAL FINDINGS WERE OBSERVED DURING FAILURE ANALYSIS BUT WERE NOT REPORTED BY THE CUSTOMER. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. THE BLADE EXHIBITED MECHANICAL INDENTATIONS. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISUSE/MISHANDLING. IMAGES THAT WERE PROVIDED BY THE CUSTOMER WERE REVIEWED. THE IMAGES SHOWED THE HARMONIC ACE WITH NO VISIBLY MISSING FRAGMENTS. NO OTHER CONCLUSION COULD BE DRAWN BASED ONLY ON A REVIEW OF THE PROVIDED IMAGES. A LOG REVIEW WAS PERFORMED AND IT WAS FOUND THAT THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4). NO OTHER COMPLAINTS WERE IDENTIFIED FOR THIS HARMONIC ACE INSTRUMENT DURING A COMPLAINT HISTORY REVIEW FOR THE SITE. 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. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS REPORTED THAT, DURING THE OPERATION, THE PATIENT REPORTEDLY SUFFERED FROM \"A LOT OF BLEEDING.\" ERROR MESSAGES RELATED TO THE HARMONIC ACE INSTRUMENT WERE OBSERVED DURING THE PROCEDURE, HOWEVER COULD NOT BE CONFIRMED THROUGH FAILURE ANALYSIS. IN ADDITION, THE INSTRUMENT WAS FOUND TO HAVE A CRACKED BLADE AND DAMAGED BLADE (MECHANICAL INDENTATIONS/BURRS) WHICH WERE ATTRIBUTED TO MISHANDLING/MISUSE. THE CAUSE OF THE BLEEDING REMAINS UNKNOWN. THERE WAS NO REPORT OF ANY POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "265988066", "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 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. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (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": "" } ] }