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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA III

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  Class 2 Device Recall EVIS EXERA III see related information
Date Initiated by Firm October 16, 2023
Date Posted November 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-0419-2024
Recall Event ID 93335
510(K)Number K131780  
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
Product PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Code Information UDI-DI 04953170305191 Serial Numbers 2302719, 2516751
Recalling Firm/
Manufacturer		 Aizu Olympus Co., Ltd.
3 Chome 1-1
Niiderakita
Aizuwakamatsu Japan
For Additional Information Contact Cynthia Ow
647-9993203
Manufacturer Reason
for Recall		 Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
FDA Determined
Cause 2		 Process control
Action On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or Cynthia.Ow@Olympus.com.
Quantity in Commerce 24 incorrectly repaired units
Distribution Domestic distribution to FL, KY, MA, NJ, NY, and PA
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 = FDF and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORP.
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