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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 September 25, 2023
Date Posted November 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-0337-2024
Recall Event ID 93222
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Hysterofiberscope-For endoscopic diagnosis within the uterus
Models:
HYF-XP
Code Information UDI-DI: 04953170340178
Recalling Firm/
Manufacturer		 Aizu Olympus Co., Ltd.
3 Chome 1-1
Niiderakita
Aizuwakamatsu Japan
For Additional Information Contact SAME
242-282111
Manufacturer Reason
for Recall		 Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
FDA Determined
Cause 2		 Under Investigation by firm
Action Olympus America issued Urgent Medical Device Correction letter on Sept. 25, 2023 to Endoscopy, Respiratory, Pulmonary and Urology Departments, Risk Management Department. Letter states reason for recall, health risk and action to take: Our records indicate that Olympus has serviced your flexible endoscope at one of our Olympus repair facilities. Following repair activities, Olympus uses a water flush of endoscope channels as part of our final endoscope channel inspection, and we subsequently dry the endoscope channels with compressed filtered air. Olympus discovered that our channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Olympus is in the process of implementing a validated drying process at our repair centers. In the meantime, Olympus has established interim processes to perform an additional inspection of your scope for water prior to return. 1. Ensure your users are knowledgeable on the content of this letter. 2. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at olympus2806@sedgwick.com or by fax at 844-294-7184. For any questions about the acknowledgement form, please call the Sedgwick team at 888-667-1504. 3. Olympus requests that you report complaints, including infections, and endoscopes returned wet from our repair centers 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. If you require additional information, please do not hesitate to contact me at (647) 999-3203 or Cynthia.Ow@Olympus.com.
Quantity in Commerce 16 units
Distribution Worldwide - 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.
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