{ "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": "2955842-2026-20833", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260409", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20260316", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260409", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251016", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "896903", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260409", "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": "480275-12", "catalog_number": "480275", "lot_number": "K10251016 0230", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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)281031(10)K10251016", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Seal" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/21/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260601", "health_professional": "Y", "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": "20260409", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension" ] } ], "distributor_city": "", "date_report": "20260506", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24837753", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260317", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "401557580", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS CONFIRMED THE REPORTED EVENT. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE AT THE TIP AND MIDDLE OF THE BLADE. ONE OF THE BLADE EDGES WAS INDENTED. THE CUTTING EDGE DID NOT HAVE CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A CRACKED BLADE. AS A RESULT, INSTRUMENT FAILED THE ENERGY RECOGNITION TEST. 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 INSTRUMENT FAILED ENERGY RECOGNITION. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. THE INSTRUMENT FAILED THE ENERGY RECOGNITION TEST, INSTRUMENT GENERATED MESSAGE \" TIGHTEN ASSEMBLY\"; ATTRIBUTED TO THE CRACKED BLADE." }, { "mdr_text_key": "401557801", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "397989271", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "397989272", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE PATIENT SUSTAINED POSTOPERATIVE BLEEDING AND REQUIRED A SUBSEQUENT PROCEDURE. TWO HARMONIC ACE INSTRUMENTS WERE USED DURING THE PROCEDURE; THE FIRST INSTRUMENT STOPPED WORKING AND PRODUCED A MESSAGE OF \"REACTIVATION.\" THE INSTRUMENT WAS REPLACED WITH A BACKUP AND THE PROCEDURE CONTINUED. BOTH INSTRUMENTS CAUTERIZED THE TARGETED TISSUE WITHOUT ISSUE; NO BLEEDING WAS PRODUCED AFTER USE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU), WHERE POSTOPERATIVE LABS WERE OBTAINED AND WERE WITHIN NORMAL LIMITS. APPROXIMATELY TWO HOURS LATER, THE PATIENT SUDDENLY BECAME HYPOTENSIVE AND WAS EMERGENTLY BROUGHT BACK TO THE OPERATING ROOM FOR A LAPAROTOMY. 2 LITERS OF BLOOD WERE FOUND WITHIN THE ABDOMEN, AND AN ACTIVE BLEED WAS NOT IDENTIFIED. THE SURGEON SUSPECTS THE BLEEDING COULD HAVE ORIGINATED FROM THE RIGHT GASTROEPIPLOIC VESSEL, BUT IT WAS UNCONFIRMED. THE PATIENT IS REPORTED TO BE RECOVERING WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/06/2026" } ] }