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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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NCAR Recall

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Reference Number:	mdprc 045 09 15 000
Date submitted:	9/8/2015

Manufacturer:	Intuitive Surgical Inc
Device Type:	Vinci Xi Surgical System
Description:	Robotic surgical system
Medical Device Identifier:	IS4000
Reason of Field Safety Corrective Action:	Intuitive Surgical has received a small number of complaints regarding the “Exposed Knife Blade” recoverable fault for the Xi Stapler with Xi System P4 version software. With this “Exposed Knife Blade” recoverable fault, the Stapler firing is interrupted prior to the completion of the full staple line. With this known, recoverable fault, formed staples precede the cut line; however, an exposed knife blade remains with incomplete staple formation at the distal end.
Remedy Action:	An Intuitive Surgical Representative will schedule a software upgrade for your da Vinci Xi system between calendar quarter 3 and 4 of 2015
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCAR
Source Ref. Number:	CH-2015-09-03-065
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Vk_20150902_04-e1.pdf

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