{ "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": "2026-10-13", "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": "+1(408)5", "event_type": "Injury", "report_number": "2955842-2026-35098", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20260812", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20260716", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(408)523-2100", "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": "20260813", "manufacturer_contact_f_name": "Izabel", "device_date_of_manufacturer": "20260507", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "65201", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260812", "brand_name": "da Vinci Energy", "generic_name": "Vessel Sealer Curved", "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": "480522-02", "catalog_number": "480522", "lot_number": "K13260507 0086", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20260804", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Deliver Energy", "Failure to Seal" ], "reporter_state_code": "UT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/31/2026", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260925", "health_professional": "N", "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": "20260812", "sequence_number_treatment": [ "da Vinci Instruments and Accessories." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20260925", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50223201", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260716", "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": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15956499704", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "The VSC instrument has been returned to Intuitive Surgical, Inc. (ISI) for evaluation but analysis has not yet been completed.The VSC instrument logs show that it was installed one time on Universal Surgical Manipulator (USM) #4. The logs show 74 seal events with 5 events indicating a high impedance situation. Thirty-four cut events were also recorded. The logs do not show any instrument related errors. The instrument was used for about 15 minutes.A review of images and a video provided by the customer was conducted. One image shows a VSC instrument positioned near target anatomy. Another image shows the VSC instrument grasping tissue. The video depicts an excised anatomical structure. Based on the images and video provided, no evidence of possible insufficient sealing could be identified." }, { "mdr_text_key": "15456499703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that during a da Vinci-assisted small bowel resection procedure, the Vessel Sealer Curved (VSC) instrument produced insufficient seals. While sealing vessels of the small bowel mesentery branches of the superior mesenteric artery (SMA), the visceral peritoneum was divided on one side to decrease the thickness and isolate the vessels for better sealing. The vessels were double sealed. Initially, the seals looked hemostatic. However, on the thin part of the mesentery, some seals immediately bled after division. This occurred multiple times throughout the procedure. The insufficient seals and oozing required additional sealing and monitoring to ensure the seals would stay intact. The patient had Crohn's disease but the tissue was not edematous or thick. The procedure was completed robotically, the patient is recovering well with no postoperative complications." } ], "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": "09/25/2026" } ] }