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 101 12 18 000
Date submitted:	12/24/2018

Manufacturer:	Intuitive Surgical Inc
Device Type:	da Vinci Harmonic ACE for use with your da Vinci S and Si systems
Description:	Surgical equipment
Medical Device Identifier:	PN 400272
Reason of Field Safety Corrective Action:	Intuitive Surgical identified that the sterile package for the insert can become damaged during transit. This damage can lead to a breach of the sterile barrier and potential for patient infection.
Remedy Action:	-Immediately stop using all da Vinci Harmonic ACE inserts. Further investigation is underway but at this time the issue has not been associated with other EndoWrist instruments, accessories or Xi Harmonic instruments. -Please forward this communication to surgeons using the Harmonic ACE instrument, Risk Managers, OR Directors, and any other medical staff who perform da Vinci procedures. Intuitive will be following up shortly with a formal letter. Harmonic ACE inserts can be returned for credit through the standard RMA process. We will follow up with information on when corrected product will be available.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	946D42F95E29A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Intuitive Surgical.pdf

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