SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 020 03 17 000
Date submitted:	3/7/2017

Manufacturer:	Smith & Nephew
Device Type:	DYONICS Battery Power Hand Pieces
Description:	Electro mechanical medical device
Medical Device Identifier:	Product No.: 72204114, 72204091, 72204092, 72204093 For more details see attached FSN
Reason of Field Safety Corrective Action:	Smith & Nephew, Inc. has initiated a Field Correction for the DYONICS Battery Power Hand Pieces due to an error in the Operator Manual. The Operator Manual contains incorrect dry time for Pre-vacuum Steam sterilization and Gravity Displacement Steam sterilization cycles. The Operator Manual incorrectly states the minimum dry time as “8 minutes” for all devices; however, the correct dry times should be longer and are provided in the attached FSN
Remedy Action:	Awareness notice to be circulated to the customers
Athorized Representative/Importer/Distributor:	Alhaya medical co.
Report Source:	NCMDR
Source Ref. Number:	AA0ADE4092264
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Smith & Nephew.pdf

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