SFDA National Center for Medical Devices Reporting

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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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NCMDR Recall

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Reference Number:	mdprc 149 10 18 000
Date submitted:	10/30/2018

Manufacturer:	Intuitive Surgical Inc.
Device Type:	EndoWrist Monopolar Curved Scissors
Description:	Robotic surgical system
Medical Device Identifier:	Part Numbers: 420179-20, 470179-18 & 470179-17 All Lots
Reason of Field Safety Corrective Action:	Intuitive Surgical has become aware that some of these units have experienced distortion due to exposure to the high temperatures found during the standard reprocessing process.
Remedy Action:	1. Always inspect the instruments prior to use for any damage and do not use an instrument if it is damaged. Return the damaged instrument to Intuitive Surgical using the standard RMA process. (Note: The return of undamaged product is not required.) 2. Inform all da Vinci personnel who are involved with da Vinci Surgery at your site. 3. Complete the attached Acknowledgement Form and return it via email to Intuitive Surgical as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	932BAD131E19C
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Intuitive Surgical Inc.pdf

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