EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to b...

FDA Device Recall #Z-2807-2015 — Class II — March 26, 2015

Recall Summary

Recall Number Z-2807-2015
Classification Class II — Moderate risk
Date Initiated March 26, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olympus America Inc.
Location Center Valley, PA
Product Type Devices
Quantity 6109

Product Description

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Reason for Recall

New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.

Lot / Code Information

Model: TJF-Q180V, all sold units

Other Recalls from Olympus America Inc.

Recall # Classification Product Date
Z-0432-2014 Class II TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Gri... Sep 27, 2013
Z-0329-2014 Class II Olympus Endoscopic Flushing Pump, Model OPF-2. ... May 20, 2013
Z-1277-2013 Class II Olympus SurgMaster UES-40 electrosurgical unit ... Nov 10, 2009

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.