EPK-i8020c Video Processor
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Product Information
Specifications:
- Product Name: PENTAX Medical Video Processor EPK-i8020c
- Model: EPK-i8020c
- Software Update: Light Limit Mode
- Compatibility: PENTAX Medical i20c Video Endoscope Series
Product Usage Instructions
Light Limit Mode Function:
The Light Limit Mode function on the EPK-i8020c Video Processor
allows users to control the amount of light emitted from the
endoscope.
How to Use Light Limit Mode:
- Touch and hold the button to activate Light Limit Mode. The
button will turn blue, indicating decreased light output. - An icon will be displayed on the monitor screen when Light
Limit Mode is enabled. - To deactivate Light Limit Mode, touch and hold the button
again. The light output will return to its previous intensity.
FAQ
Frequently Asked Questions:
Q: What should I do if I notice reduced light
output?
A: Check if Light Limit Mode is activated. If
so, deactivate it by touching and holding the button.
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June 30, 2025
URGENT MEDICAL DEVICE CORRECTION
For United States Customers
Re: PENTAX Medical Video Processors Software Update for EPK-i8020c for Light Limit Mode
Dear PENTAX Medical Customer,
This letter is to inform you that PENTAX Medical is conducting a field action regarding the PENTAX Medical Video Processor EPK-i8020c.
As previously announced in our Field Safety Notice of January 2025, (2025-001-C i20c Customer Advisory Notification Letter) when the PENTAX Medical i20c Video Endoscope Series are used in combination with the PENTAX Medical INSPIRA Video Processor EPK-i8020c, the following phenomenon may occur:
In certain cases, during endoscopic procedures using the EPK-i8020c Video Processor, the image may appear reddish or dark. Globally, Pentax has received fifty-nine complaints related to this issue. Some users have observed smoke-like steam and noted that the light guide at the tip of the endoscope used is heated during or after use. In some cases, this phenomenon has been associated with patient mucosal irritation or injury. Serious injuries have occurred due to the failure mode associated with this recall. We have reports of two serious injuries.
PENTAX Medical is conducting a subsequent Field Corrective Action concerning the PENTAX Medical Video Processor EPK-i8020c.
PENTAX Medical updated the Video Processor EPK-i8020c software to add a new function called “Light Limit Mode.” This mode restricts the light output emitted from the distal end of the endoscope and is used to limit the maximum light intensity. When bleeding, such as hematemesis or hematochezia, is anticipated, activate the Light Limit Mode before inserting the endoscope. Additionally, if heavy bleeding is observed during the examination or treatment after inserting the endoscope, promptly activate the Light limit mode.
PENTAX Medical has also updated Instructions for Use (IFU) for the EPK-i8020c Video Processor to provide detailed information on the Light Limit Mode function.
Your PENTAX Medical representative will provide an overview of the Light Limit Mode software and will address any questions you may have.
For United States Customers Only
MKGI-5390EN-U Rev 1 (v1.3)
Customer Instructions: PENTAX Medical will conduct the software update on the affected devices at your facility. Your local PENTAX Medical representative will contact you to schedule the required updates for your equipment.
· Please download the Instructions for Use (IFU) for the EPK-i8020c Video Processor from the PENTAX Medical online IFU library at https://ifu.pentaxmedical.com.
· Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX Medical at customeradvisories@pentaxmedical.com.
Contact Information: PENTAX Medical regrets any inconvenience that this action may cause and appreciates your understanding and cooperation. Please be assured that maintaining product quality is our utmost priority.
Please indicate through the attached response form that you have received and understood this information, by completing it and returning it no later than July18, 2025 at: customeradvisories@pentaxmedical.com
If you have any questions regarding this action, please feel free to contact us at: · Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) · Fax: (800)-579-5432) · Email: customeradvisories@pentaxmedical.com
Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX Medical at vigilance@pentaxmedical.com.
Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Sincerely,
Seiya Raiju Chief Quality Officer PENTAX Medical
For United States Customers Only
MKGI-5390EN-U Rev 1 (v1.3)
Update to Instruction for Use (IFU).
The following descriptions shall be added to the Instructions for Use (IFU) of the EPK-i8020c Video Processor in accordance with the software update.
Light Limit Mode · This mode limits the maximum light emitted from the distal end of the endoscope. · This function is used to limit the maximum light intensity · When bleeding, such as hematemesis or hematochezia, is expected, activate the Light Limit Mode before inserting the endoscope. · If heavy bleeding is observed during the examination or treatment after inserting the endoscope, promptly activate the Light Limit Mode.
Light Limit Mode Compatible Endoscopes The table below shows the compatibility of each endoscope with the Light limit mode.
Note:
When Light Limit Mode is turned on, the amount of light decreases. If you notice reduced light output, please check that Light Limit Mode is not activated.
White balance cannot be performed when Light Limit Mode is on.
How to Use Light Limit Mode
1. To activate Light Limit Mode, touch and hold the button. The button will turn blue, and the light emitted from the tip of the endoscope will decrease.
For United States Customers Only
MKGI-5390EN-U Rev 1 (v1.3)
2. When Light Limit Mode is enabled, an icon will be displayed on the monitor screen.
3. To deactivate Light Limit Mode, touch and hold the button again. The button will return to its original color, and the light emitted from the distal end of the endoscope will return to its previous intensity.
4. After deactivating Light Limit Mode, the icon will disappear from the monitor screen, indicating that the light emission has returned to its normal intensity.
For United States Customers Only
MKGI-5390EN-U Rev 1 (v1.3)
Operation When Light Limit Mode is Enabled or Disabled Light limit mode is Enabled:
i -SCAN Profile Settings While Light limit mode is Activated The i -SCANProfile can be modified or loaded during Light Limit Mode; however, functions restricted by Light Limit Mode cannot be used through the i-SCANProfile. For further details, please refer to the table below.
Light limit mode is Disabled: The display switches to a single – screen White Light state, regardless of the state prior to activation. Conditions Preventing Activation of Light Limit Mode: Light Limit Mode will be disabled and cannot be used if any of the following conditions are met:
OE (Optical enhancement) OE cannot be used while the Light Limit Mode is activated. OE is disabled when the scope is removed, and it does not automatically switch to OE mode when the scope is reconnected.
For United States Customers Only
MKGI-5390EN-U Rev 1 (v1.3)
Name Address, State, Zip
FIELD CORRECTION RESPONSE FORM
RESPONSE IS REQUIRED
REF: 2025-002-C
PENTAX Medical EPK-i8020c Video Processors Software Update for Light Limit Mode
Contact Information Name Title Telephone Fax Number Email address
I have read and understood the instructions provided in the customer notification letter. I have received the PENTAX Medical weblink and instructions and have downloaded the Instructions for Use (IFU) for
EPK-i8020c.
According to our record the following product/serial numbers are affected by this notification
Model EPK-i8020c
Serial Number(s)
Signature of Receipt and Acknowledgement:
Date:
Upon completion of the form and signing, please return the form by either one of the following methods: · Faxing this completed form to PENTAX Medical QA/RA Department at 201-799-4063 (alternate 201-391-4189) · Email a pdf copy of the completed form to customeradvisories@pentaxmedical.com.
If you have any questions regarding this action, please feel free to contact your PENTAX Medical Territory Manager or PENTAX Medical Customer Service at 800-431-5880 (8:30am 5:00 pm EST, Monday Friday).
MKGI-5391EN-U Rev 1 (v1.1)
For United States Customers Only
Documents / Resources
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PENTAX EPK-i8020c Video Processor [pdf] User Manual EPK-i8020c, EPK-i8020c Video Processor, EPK-i8020c, Video Processor, Processor |