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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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  Class 2 Device Recall Olympus see related information
Date Initiated by Firm November 02, 2021
Create Date December 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-0379-2022
Recall Event ID 88981
510(K)Number K143153  
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
Product EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V

Model Number: TJF-Q180V
Code Information All serial numbers. UDI: 04953170339967
Recalling Firm/
Manufacturer
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact SAME
484-896-5000
Manufacturer Reason
for Recall
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
FDA Determined
Cause 2
Under Investigation by firm
Action Olympus issued Urgent Medical Device Corrective Action on 11/02/21 via Federal Express Second Day Delivery. Letter states reason for correction, health risk and action to take: Actions to be taken by the end user: Our records indicate that your facility has purchased one or more TJF-Q180V duodenoscopes. Olympus requests you to take the following actions: 1. Consider transitioning from TJF-Q180V to a next generation duodenoscope through the Olympus incentive program. 2. Increase the frequency for sending TJF-180V duodenoscopes for preventative maintenance from annual to every six months. Customers who notice any issue or have any concern can send their duodenoscope back to Olympus for evaluation and potential repair at any time. 3. Evaluate existing duodenoscopes: A. Inspect your inventory for the referenced devices and identify any device with the model number specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. B. Carefully read the content of this Medical Device Correction Action as well as the attached Checklist. The interactive Checklist can be obtained through our website at: https://medical.olympusamerica.com/TJFQ180VChecklist C. This Checklist should be used in combination with the TJF-Q180V Operation and Reprocessing Manuals when conducting inspections of the TJF-Q180V. Ensure all personnel are completely made aware and knowledgeable on the new Checklist. For your reference, the sections of the TJF-Q180V Operation and Reprocessing Manuals which contain the inspection checks are detailed below. 3.2 Inspection of the endoscope: Operation manual (RC2408 06) 3.6 Inspection of endoscopic system: Operation manual (RC2408 06) 5.3 Leakage testing of the endoscope: Reprocessing manual (RC2409 05) 4. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0402 and provide your contact informati
Quantity in Commerce 14,447 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FDT and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORP.
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