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 024 05 18 001
Date submitted:	5/30/2018

Manufacturer:	Medtronic
Device Type:	Covidien Endo GIA™ Articulating Loading Units
Description:	Surgical staple, non-biodegradable
Medical Device Identifier:	Multiple Items and Lots are provided in the attached FSN. ........................ NCMDR update codes: Covidien Endo GIA™ Articulating Reloads. Item code: EGIA45AMT, EGIA60AMT, EGIA60AXT, EGIA60AVM, SIG60AXT, SIG30AVM, EGIA45AV, EGIA45AXT, EGIA45AVM, EGIA45CTAVM, SIG30AMT, SIG30CTAVM, SIG45CTAVM, SIG30CTAV & SIG45AXT See attachment for details*
Reason of Field Safety Corrective Action:	This voluntary recall is being conducted due to the potential for a device to be missing the sled component. The sled component is responsible for staple deployment. Without the sled, no staples would be deployed. Use of a product with this issue may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. Medtronic has received four reports of injury related to this issue.
Remedy Action:	Return the affected device to the manufacturer.
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	DA63DC81262C0, 6D0812CFE723D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic SA.pdf

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