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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 156 06 15 000
Date submitted:	6/29/2015

Manufacturer:	Intuitive Surgical Inc
Device Type:	da Vinci Xi Endowrist Instruments
Description:	Endotherapy electrosurgical diathermy system electrode, reusable
Medical Device Identifier:	Not specific to a lot or lots of product. All EndoWrist instruments used with the da Vinci Xi Surgical System and covered by the following user manuals : Czech 552286-01 553262-01 Dutch 552288-01 553265-01 English 551708-01 552898-01, 552628-01 French 552291-01 553267-01 German 552292-01 553268-01 Italian 552296-01 553269-01 Korean 552298-01 553270-01 Norwegian 552301-01 553271-01 Romanian 552304-01 553307-01 Spanish 552309-01 553273-01 Swedish 552310-01 553274-01 Traditional Chinese 552284-01 553263-01 Turkish 552311-01 553275-01
Reason of Field Safety Corrective Action:	The purpose of this letter is to advise you that Intuitive Surgical is initiating a voluntary correction related to the da Vinci Xi Reprocessing Manuals for the EndoWrist instruments.
Remedy Action:	Discontinue the use of Getinge Turbo 88 Washer/Disinfector with Getinge Clean MIS detergent for reprocessing da Vinci Xi instruments.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCAR
Source Ref. Number:	CH-2015-06-22-045
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Vk_20150612_03-e1.pdf

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