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U.S. Department of Health and Human Services

Class 2 Device Recall Ureteroreno fiberscope URFP6

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  Class 2 Device Recall Ureteroreno fiberscope URFP6 see related information
Date Initiated by Firm January 17, 2018
Create Date July 20, 2018
Recall Status1 Terminated 3 on December 04, 2019
Recall Number Z-2519-2018
Recall Event ID 79701
510(K)Number K172298  
Product Classification Ureteroscope and accessories, flexible/rigid - Product Code FGB
Product Uretero-reno fiberscope URF-P6
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact
484-896-5000
Manufacturer Reason
for Recall		 Breakage of the endoscope's insertion tube bending section during surgical procedures.
FDA Determined
Cause 2		 Device Design
Action On 1/17/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures.Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-P6/P6R models; 2.Olympus will contact your facility to make arrangements for return of your URF-P6/P6R fiberscope(s) for the device exchange. You will be provided instructions on returning the URF-P6/P6R for this exchange; 3.Olympus has discontinued previously distributed copies of the URF-P6/P6R Reprocessing Manual and the Operation Manual Inspect your inventory of the Reprocessing Manual and the Operation Manual, and discard any existing inventory of the URF-P6/P6R Reprocessing Manual and the Operation Manual; 4.Implement use of the enclosed Reprocessing Manual which recommends only sterilization methods, and the enclosed Operation Manual; 5. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new reprocessing instructions in the new Reprocessing Manual; 6. If you may have further distributed the URF-P6/P6R, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter; 7. Please indicate on the enclosed questionnaire that you have received this notification. Return of the enclosed questionnaire will be deemed to be a request for a new replacement URF-P6/P6R fiberscope(s). Fax the completed form to 484-896-7128.
Quantity in Commerce 1062
Distribution US Nationwide. Canada and Mexico
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGB and Original Applicant = Olympus Medical Systems Corp.
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