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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus URETERORENO FIBERSCOPE

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  Class 2 Device Recall Olympus URETERORENO FIBERSCOPE see related information
Date Initiated by Firm April 20, 2022
Create Date June 13, 2022
Recall Status1 Open3, Classified
Recall Number Z-1264-2022
Recall Event ID 90195
510(K)Number K172298  
Product Classification Ureteroscope and accessories, flexible/rigid - Product Code FGB
Product Olympus URETERO-RENO FIBERSCOPE
Model: URF-P6R
Code Information UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299
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		 Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Olympus notified Urgent Medical Device Correction letter on 4/20/22 via email. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. The model and serial number can be found on the device as illustrated. 2. An Olympus representative will contact you to make arrangements for return of your affected device. Olympus will repair your unit free of charge. In the meantime, follow the instruction manual for inspection of the device before use. Should any irregularities be identified, including a loose parts, do not use the device and contact Olympus for repair. 3. Olympus will arrange for a service loaner in an effort not to disrupt clinical care. Contact me directly at 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
Quantity in Commerce 4 units
Distribution CA FL MA MD MI NJ OH PR WI
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 = FGB and Original Applicant = Olympus Medical Systems Corp.
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