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FDA MedWatch - ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions


AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing

ISSUE: FDA is providing an important update to the February 19, 2016 Safety Communication to inform users about a design issue with the PENTAX ED-3490TK duodenoscope that could increase the risk of patient infection. This safety communication contains updated recommendations to help prevent the spread of infection associated with the use of these devices. Since the February 2016 communication, PENTAX provided the FDA with additional information related to a potential risk associated with the design and manufacturing of the ED-3490K duodenoscope. Cracks and gaps in the adhesive that seals the device's distal cap to its distal tip can occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.

In February 2016, PENTAX issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to
replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and continues to recommend that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions
and implement them, if you have not already done so.

The validated manual reprocessing procedures for the ED-3490TK duodenoscope outlined in the February 2016 Safety Communication remain the same.

RECOMMENDATION: FDA recommends that facilities and staff that use and reprocess PENTAX's ED-3490TK Video Duodenoscope do the following:

  • Implement the reprocessing procedures for PENTAX's ED-3490TK Video Duodenoscope in accordance with the manufacturer's reprocessing instructions issued in February 2016.
  • In lieu of manual high-level disinfection, facilities may opt to use the ED-3490TK Video Duodenoscope with an Automated Endoscope Reprocessor (AER) that has provided validation data and test reports to FDA that demonstrate acceptable high-level disinfection or liquid chemical sterilization of duodenoscopes. See this link for updated AER Validation Testing Statuses.
  • Immediately remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, cracks and gaps in the adhesive that seals the device's distal cap or other signs of wear or damage.

Train appropriate staff on PENTAX's validated reprocessing instructions and implement them, if you have not done so already.

Contact your PENTAX Medical sales representative if you need to arrange for in-servicing and training regarding the validated duodenoscope reprocessing procedures. PENTAX will also follow up with customers to assess their in-servicing or training needs. 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: <>

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