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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 010 01 17 000
Date submitted: 1/3/2017
Manufacturer:FUJIFILM Medical Systems
Device Type:ED-530 XT and ED-530XT8 Duodenoscopes
Description:Duodenoscopes
Medical Device Identifier:Duodenoscopes: (1) ED-530XT, (2) ED-530XT8
Reason of Field Safety Corrective Action:Manufacturer Issues Revised Manual Reprocessing Instructions
Remedy Action:The following key changes have been made in the Operation's Manual’s “Preparation and Operation” and “Cleaning, Disinfection and Storage" sections:

(1) Precleaning •During immersion of the scope tip in detergent solution, move the forceps elevator back and forth and aspirate detergent solution while the forceps elevator is raised and while lowered.

(2) Manual Cleaning •Additional brushing of the distal tip, forceps elevator, and elevator recess first using the existing Fujifilm valve cylinder cleaning brush (model number WB11002FW2) and then using the new disposable cleaning brush (model number WB1318DE). •Additional flushing of detergent and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered. •Additional flushing steps and increased channel flushing volumes of detergent and rinse water.

(3) Manual High-Level Disinfection •Additional flushing of disinfectant and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered. Additional raising and lowering of the elevator while immersed in disinfectant solution and rinse water. •Additional flushing steps and increased flushing volumes of disinfectant and rinse water through the duodenoscope’s internal channels.
Athorized Representative/Importer/Distributor:AlJeel Medical
Report Source:NCMDR
Source Ref. Number:A27692, 69253EE9F52AA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: FUJIFILM_Corporation_-.pdf