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U.S. Department of Health and Human Services

Class 2 Device Recall OLYMPUS TJFQ190V Duodenoscope

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  Class 2 Device Recall OLYMPUS TJFQ190V Duodenoscope see related information
Date Initiated by Firm July 27, 2023
Date Posted August 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2467-2023
Recall Event ID 92703
510(K)Number K220587  K202661  K193182  
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
Product EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Code Information Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 Recent reports of patient infection.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were sent an Urgent Medical Corrective Action notification dated 7/27/2023. This action is being initiated due to the firm becoming aware of and FDA inquiring about recent reports of infections and positive cultures. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus Service, and informing users about an updated manual intended to improve comprehension of existing reprocessing steps. Additional enhancements to the manual include the use of reprocessing timelines and simplified text/visualization techniques. The manual is available on the customer web portal and paper copies, along with wall charts, are available to be mailed to your facility. The notification also emphasises the required inspection of the forceps elevator mechanism, to be performed once a year or every 100 reprocessing cycles, and encourages consignees to consider incorporating voluntary routine microbiologic surveillance of endoscops as part of their quality improvement/assurance efforts. Consignees are asked to complete and return the provided response form to Sedgwick via email at ollympus7521@sedgwick.com or by fax to 888-208-4588. Questions can be directed by phone to 866-912-9552. Customers can also contact Ashley Mitch at Olympus by phone at 484-553-1029 or by email at Ashley.Mitch@olympus.com with any additional concerns.
Quantity in Commerce 6,426 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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