Wednesday, May 4, 2016

PENTAX: US URGENT FIELD CORRECTION: IFU Addendum for Endoscopes with Instrument Channel

"April 7, 2016

Dear Valued Customer,

PENTAX Medical has become aware that operational/cleaning accessories and therapeutic devices can become lodged in an endoscope's instrument channel. If not detected, the blocked instrument channel can result in ineffective reprocessing and/or the introduction of debris and/or device components into a patient during a subsequent procedure, posing a risk of cross-contamination. As a result, PENTAX Medical is issuing Addendum 388 R01 to the Operation and Reprocessing Instructions for Use (IFU) for all models of endoscopes with instrument/suction channels.

The purpose of the Addendum is to remind customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.g., clips, stents, balloons, etc.) passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. In such a case, contact your local PENTAX Medical service facility to have the endoscope repaired.

Contact Information
If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:

Tel: 800-431-5880 ext. 2064
 (8:30 AM-5:00 PM, M-F, EST)
Fax: 201-799-4063

This correction is being made with the knowledge of the U.S Food and Drug Administration.

PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority."

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