"April 7, 2016
Dear Valued Customer,
PENTAX Medical video processors and light sources are utilized with a disposable water bottle assembly comprised of a tubing adaptor and sterile water bottle that is intended to provide water and air for the cleaning of the objective lens of PENTAX Medical endoscopes. It has come to our attention that the PENTAX Medical Video Processor EPK-i5010 has been shipped with a reusable PENTAX Medical water bottle assembly (OS-H4) which has not been cleared for use with the EPK-i5010 in the United States. As a result, all customers that have previously received an OS-H4 water bottle with an EPK-i5010 for use with an endoscope with an air/water channel should discard these bottles and should use the PENTAX Medical DispoCap Air Tubing in their place. Users of other PENTAX Medical video processors and light sources should also discard their reusable PENTAX water bottle assemblies (OS-H2 &OS-H4) and replace them with the PENTAX Medical DispoCap Air Tubing. In addition, PENTAX Medical is issuing an Addendum to the Operation and Reprocessing Instructions for Use (IFU) for certain models of endoscopes to remove non-applicable steps as they relate to the water bottle assembly in the pre-cleaning of the endoscope in the procedure room.
The pre-cleaning steps in the Operation and Reprocessing IFUs include an instruction to turn the lever on the water bottle to the 'drain' position in order to empty the water channel, however, this action is unique to the reusable PENTAX Medical water bottle and is not relevant for a disposable water bottle assembly. As a result, PENTAX Medical is issuing the attached IFU Addendum which instructs customers to disregard this step. The pre-cleaning instructions are otherwise accurate and complete as it pertains to the disposable water bottle assembly. This addendum should be placed in the Operation and Reprocessing IFUs originally provided with the endoscope at the time of purchase. Please ensure that user departments discard andy PENTAX OS-H2/OS-H4 water bottles and trasition to the PENTAX Medical DispoCap Air Tubing (Model 100160P) for use with a disposable sterile water bottle.
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
Please contact PENTAX Medical customer service to place orders for the PENTAX Medical DispoCap Air Tubing, Model 100160P.
Tel: 800-431-5880
Email: salessupport2@pentaxmedical.com
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 patients as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority."
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