—#155667

Product

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

FDA product code: FFS — Image, Illumination, Fiberoptic, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K072521
Affected lot / code info: Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306

Why it was recalled

Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

Root cause (FDA determination)

Device Design

Action the firm took

Cook Inc. initiated a voluntary recall of multiple products because it was identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Notices were mailed on 05/9/2017 via courier. Customers were asked to do the following: Distribution of the VueOptic Visualization Source and Flexor Vue Deflecting Endoscopic System products will not occur until the reprocessing instructions in the Instructions for Use have been corrected. You can continue to use the VueOptic Visualization Source and Flexor Vue Deflecting Endoscopic System by following the attached document for Reprocessing Instructions. Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Implement the provided updated Reprocessing Instructions. 3. Return the required Acknowledgement and Receipt Form within 30 days. 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email (fieldactionsna@cookmedical.com). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Domestic: FL IN LA MS NC TX Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom, VA/DOD:None

Timeline

Recall initiated: 2017-05-03
Posted by FDA: 2017-06-05
Terminated: 2018-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.