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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 002 07 11 000
Date submitted: 7/3/2011
Manufacturer:Intuitive Surgical Inc
Device Type:da Vinci Intuitive Surgical System
Description:Telemanipulation
Systems, Surgical,
Minimally Invasive
Medical Device Identifier:da Vinci Si Surgical System (IS3000). Serial no: SH0565
Reason of Field Safety Corrective Action:This field correction is being initiated due to failure of a retention component in the Master Tool Manipulator (MTM – commonly referred to as the “Master”) spring counterbalance subsystem.
Remedy Action:The surgeon should always assure that he/she does not release the grip of the masters while his/her head is in the stereo viewer. Intuitive Surgical has designed reinforcing caps for the retention component to correct the problem with the MTM subsystem.
Athorized Representative/Importer/Distributor:Gulf Medical Co. Jeddah (02) 6512828
Report Source:NCMDR
Source Ref. Number:A7D8F7B5B93E4
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Manufacturer letter.pdf