التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

All affected systems remain safe for use if the following instructions are followed:
-	Prior to each use, inspect all the Instrument Carriages on your affected da Vinci X and Xi systems using the ‘Instrument Carriage Inspection Instructions’ outlined in Appendix A in the attachment. If an Instrument Carriage fails the inspection or if there is any concern, do not use the USM and notify Intuitive. If 3 of the 4 USM Instrument Carriages pass the inspection, the da Vinci X or Xi system may be used per instructions in section Three-Arm procedure of the da Vinci X and Xi systems user manual.
-	Please continue to adhere to instructions in the da Vinci X and Xi User Manual
and hold the USM/arm by its gray handle during manual moving and positioning of the arm. Do not use the Instrument Carriage to manually reposition the USM when the system is powered off or in a fault condition. If this is unavoidable in the event of an emergency, please Stop Using that USM and notify Intuitive. An Intuitive representative will schedule a visit to perform inspection and necessary correction.
-	If instruments cannot be manipulated in a precise and controlled manner, contact Intuitive Technical Support immediately to prevent tissue injury. 

The Intuitive Representative will schedule a site visit to inspect the insertion linear rail and replace the USM if necessary.

Manufacturer action: Instructions and correction.

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