Source

SFDA- Saudi Food & Drug Authority

https://ade.sfda.gov.sa/Fsca/PublishDetails/253

Product

PENTAX MEDICAL Video Processor EPK-i8020c and PENTAX Medical Video Endoscopes of the i20c series

Manufacturer

HOYA Corporation.

Local agent

Axis Medical Technology LLC.

The affected products

Model name: EPK-i8020c

General name: PENTAX Medical Video Processor

Basic UDI-DI: 49613330l0301XN

Model name: EC34-i20cL, EC34-i20cF, EC34-i20cM, EC38-i20cL, EC38-i20cF, EC38-i20cM

General name: PENTAX Medical Video Colonoscope

Basic UDI-DI: 4961333010102XE

Model name: EG27-i20c, EG29-i20c

General name: PENTAX Medical Video Upper GI Scope

Basic UDI-DI: 496l333010104XJ.

Reason

Under certain conditions during endoscopic procedures using a combination of the PENTAX Medical Video Processor EPK-i8020c and the PENTAX Medical Video Endoscopes of the i20c series the observed image can become reddish or dark. some users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient

Action

1. Refer to the attachment for more details