Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olym
Summary
The FDA issued a Class II for Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF by Olympus Corporation of the Americas. Reason: Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bl.
Details
Source
Device Recall
External ID
Z-1071-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
Lot/Code Info: UDI: 04953170441271 All lot numbers
Quantity Affected: 24300 units (box of 20 pieces)
Reason for Recall
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-08
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 164 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-1071-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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