FDA Updates Design and Labeling of Pentax Medical Duodenoscope, Model ED-3490TK

February 7, 2018

On February 7, 2018, the FDA cleared an update to the design and labeling for Pentax ED-3490TK duodenoscopes. This is after Pentax issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-3490TK duodenoscopes. The purpose of the recall was to replace the forceps elevator mechanism.

The design changes intend to reduce potential for leakage of patient fluids into the closed elevator channel and under the distal cap.

The FDA has been working with duodenoscope manufacturers to further enhance the safety margin of the devices and effectively demonstrate that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.

Visit the FDA online for a complete listing of actions taken on this issue. The FDA will provide updates as appropriate.

The FDA provides the following recommendations for health care professionals:

  • 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.

Recommendations for health care professinals and patients:

  • 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.
    • 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 .

The MedWatch Safety Alert, including a link to the FDA Safety Communication is available online.

 

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