FDA MedWatch - ED-530XT Duodenoscopes by Fujifilm: Safety Communication - Recall Issued, Updated Design and Labeling

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - ED-530XT Duodenoscopes by Fujifilm: Safety Communication - Recall Issued, Updated Design and Labeling

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ED-530XT Duodenoscopes by Fujifilm: Safety Communication - Recall Issued, Updated Design and Labeling

AUDIENCE: Gastroenterology, Risk Manager

ISSUE: On July 21, 2017, Fujifilm issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes. This action includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA cleared the updated design and labeling for the ED-530XT on July 21, 2017.

BACKGROUND: As noted in FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.

RECOMMENDATIONS:

• Acknowledge Fujifilm's Urgent Medical Device Correction and Removal and identify affected products in your facility.
  • Indicate if you do NOT have any affected duodenoscopes or Operation Manuals.
  • Upon receipt of the enclosed new Operation Manuals, remove and replace any older operation manuals from your facility, and destroy and dispose of properly.
• Be aware of the manual reprocessing procedures outlined in FDA's December 23, 2015 Safety Communication "FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes."
  • Continue to use these validated instructions when reprocessing Fujifilm ED-530XT duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Fujifilm ED-530XT duodenoscope.

FDA's recommendations are based on currently available information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the Safety Communication, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm567981.htm

 

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery Communications Cloud on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)