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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 047 07 15 000
Date submitted: 7/23/2015
Manufacturer:Intuitive Surgical Inc
Device Type:Instrument Arm Drapes Used with da Vinci Xi Surgical Systems
Description:Telemanipulation Systems, Surgical, Minimally Invasive
Medical Device Identifier:20 Pack Instrument Arm Drapes used with IS4000 da Vinci Xi Surgical Systems
Drape Part Nos.: 470015-05, 470015-06
Reason of Field Safety Corrective Action:Drape Pouch May Be Inadvertently Pinched between Sterile Adapter and Instrument Carriage
Remedy Action: - Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures
- Refer to the da Vinci Xi System User Manual for more information on draping the system.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCAR
Source Ref. Number:CH-2015-07-16-053
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Intuitive Surgical CH-2015-07-16-053_FSN_160715.pdf