Summary
The FDA issued a Class II for Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 by Olympus Corporation of the Americas. Reason: Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function.
Details
Source
Device Recall
External ID
Z-1262-2022
Action Date
2022-06-22
Status
Ongoing
Category
device
Product Description
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Lot/Code Info: UDI-DI: 04953170339417 Serial Number: 2456630 7171632 2769732 W501648A 2355088 2557155 2972060
Quantity Affected: 7 units
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.
Distribution
CA FL MA MD MI NJ OH PR WI
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-20
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 108 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1262-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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