{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "202943", "product_res_number": "Z-0075-2024", "event_date_initiated": "2023-09-22", "event_date_posted": "2023-10-18", "recall_status": "Open, Classified", "res_event_number": "92932", "product_code": "HIF", "k_numbers": [ "K110294", "K122180" ], "product_description": "Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.", "code_info": "UDI-DI: 04953170324147; \nAll Serial Numbers", "firm_fei_number": "2429304", "recalling_firm": "Olympus Corporation of the Americas", "address_1": "3500 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8229", "additional_info_contact": "Cynthia Ow\n484-896-5000", "reason_for_recall": "There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT: MEDICAL DEVICE CORRECTIVE ACTION notification letter dated 9/22/23 was sent to customers. \n\nAction steps to be taken by the end user: \nOur records indicate that your facility has purchased one or more of the Olympus UHI-4. Olympus requires you to take the following actions: \n1. Carefully read the content of this Field Corrective Action Letter. \n2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter. \n3. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at olympus5578@sedgwick.com or by fax at 866-367-6717. For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-4972. \n4. If you have further distributed this product, identify your customers, and forward them this Letter. Please appropriately document your notification process and let us know the end-customer feedback accordingly. \nOlympus requests that you report complaints, including any injuries associated with over insufflation during the procedure with UHI-4, to Olympus. Please report complaints to Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax.\n\nAn URGENT: MEDICAL DEVICE CORRECTIVE ACTION - UPDATE notification letter dated 10/25/23 was sent to customers.\n\nAction steps to be taken by the end user:\nOur records indicate that your facility has purchased one or more of the Olympus UHI-4. Olympus requires you to take the following actions:\n1. Inspect your inventory and identify any UHI-4 High flow insufflation unit(s). Quarantine and mark your units appropriately by your site to prevent usage. If your facility does not have alternatives or is unable to obtain alternatives, you may choose to use the UHI-4 while using extreme caution and after reviewing the information above", "product_quantity": "3136 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K193520", "K935862", "K022052", "K915051", "K942207", "K934115", "K014166", "K913873", "K080852", "K212786", "K925691", "K950219", "K973432", "K921963", "K981859", "K871928", "K905481", "K030837", "K073452", "K935639", "K173545", "K010053", "K102136", "K911479", "K922038", "K193339", "K922245", "K232401", "K923194", "K913772", "K921264", "K120151", "K000180", "K812200", "K143404", "K222812", "K992381", "K231342", "K944509", "K153513", "K111955", "K970866", "K980134", "K061387", "K922244", "K905705", "K063546", "K936155", "K222901", "K091366", "K063367", "K030469", "K041560", "K242536", "K772297", "K252318", "K915694", "K052125", "K171139", "K243527", "K905549", "K930192", "K983326", 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