Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared

AUDIENCE: Gastroenterology, Nursing, Risk Manager

ISSUE: Pentax issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance. The design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The FDA cleared the updated design and labeling for the ED-3490TK on February 7, 2018. The reprocessing instructions for the recently cleared ED-3490TK have not changed since the February 2016 update.

The FDA continues to closely monitor the association between reprocessed endoscopes and the transmission of infectious agents. Visit the FDA's Infections Associated with Reprocessed Duodenoscopes webpage for a complete listing of actions the Agency has taken on this issue. The Agency will continue to provide updates as appropriate.

BACKGROUND: 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.

RECOMMENDATION: Based on currently available information, the FDA recommends health care facilities:

Acknowledge Pentax's Urgent Medical Device Correction and Removal notification disclaimer icon and identify affected products in your facility.
Return the field correction response form.
- Indicate if you do NOT have any affected duodenoscopes or Operation Manuals.
- Upon receipt of the new Operation Manuals, remove and dispose of any older operation manuals in your facility.
Be aware of the manual reprocessing procedures outlined in FDA's January 17, 2017, Safety Communication "UPDATE: Importance of Following Validated Reprocessing Instructions for Pentax-ED-3490TK Video Duodenoscopes."
- Continue to use these validated instructions when reprocessing Pentax ED-3490TK duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Pentax ED-3490TK duodenoscope.

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 FDA Safety Communication, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm595788.htm