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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 160 11 13 000
Date submitted: 11/25/2013
Manufacturer:Intuitive Surgical Inc
Device Type:da Vinci S, Si, and Si-e Surgical Systems
Description:da Vinci S, Si, and Si-e Surgical Systems
Medical Device Identifier:da Vinci Robotic Surgical System Patient Side Carts: Part Nos.:
S (380430)
Si (380614)
Si-e (380649)
Reason of Field Safety Corrective Action:Friction within Patient Side Manipulator May Interrupt Smooth Instrument Motion
Remedy Action:An Intuitive Surgical Representative will schedule a site visit with your hospital to perform the testing and potential correction activity for the instrument arms of your system(s). The site visit is expected to take approximately 4 hours per system. Those instrument arms not passing the inspection testing will undergo maintenance to address the friction in the drivetrain.
Be aware that the friction within the instrument arm is detectable and will manifest itself as resistance at the masters.
Athorized Representative/Importer/Distributor:Gulf Medical Co, Jeddah (012)6512828
Report Source:NCAR
Source Ref. Number:CH-2013-11-21-105
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20131120_31-e1.pdf