URGENT MEDICAL DEVICE CORRECTION

Introduction and Issue

This letter informs 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 is used 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 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.

Software Update: Light Limit Mode

PENTAX Medical has 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.

Activation Guidance:

• When bleeding, such as hematemesis or hematochezia, is anticipated, 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

*1: The button is always grayed out and cannot be used.

Notes on Light Limit Mode

• 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

Activating 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.

Textual description of screenshot: A screenshot of the PENTAX Medical EPK-i8020c user interface shows the 'Lamp' setting at '0' and 'Pump' at '1'. The 'Light limit' button is visible and appears to be in an active state, indicated by a blue color. Other controls like 'Scope eject', 'Patient', 'User profile', 'White balance', and 'Setting' are also visible.

Monitor Display During Light Limit Mode

When Light Limit Mode is enabled, an icon will be displayed on the monitor screen.

Deactivating Light Limit Mode

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.

Monitor Display After Deactivating Light Limit Mode

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.

Textual description of screenshot: A screenshot of the PENTAX Medical EPK-i8020c user interface shows the 'Light Limit Mode' deactivated. The 'Light limit' button returns to its original appearance, and the light emission is expected to be at normal intensity. The screen displays patient information and operational controls similar to the activated state, but without the specific 'Light Limit Mode' indicator.

Operation Details

Operation When Light Limit Mode is Enabled or Disabled

Light Limit Mode Enabled

*1: The touch panel items are grayed out, and when the Endoscope button, Footswitch, or keyboard is configured, an error beep and message will be displayed.

i-SCAN Profile Settings While Light Limit Mode is Activated

The i-SCAN Profile can be modified or loaded during Light Limit Mode; however, functions restricted by Light Limit Mode cannot be used through the i-SCAN Profile.

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.

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 July 18, 2025 at: customeradvisories@pentaxmedical.com

Questions regarding this action:

• Tel: 1-800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)
• Fax: (800)-579-5432
• Email: customeradvisories@pentaxmedical.com

Reporting Adverse Events

• 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

Field Correction Response Form

RESPONSE IS REQUIRED

Reference Information

REF: 2025-002-C

PENTAX Medical EPK-i8020c Video Processors Software Update for Light Limit Mode

Contact Information

Name:

Address:

State, Zip:

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.

Affected Product/Serial Numbers

Signature of Receipt and Acknowledgement:

Date:

Return 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.

Further Questions

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).