Isi received the endowrist sp camera involved with this complaint and completed the device evaluation.Failure analysis identified residual soil adhered to the tip of the camera and noted that there appeared to be a piece of epoxy layer missing over the distal end fibers of the instrument.The adhered soil is due to the interaction with degraded, inert epoxy covering the fiber optic surfaces at the tip of the camera.Based on the information provided at this time, this complaint is being reported due to the following: the endowrist sp camera instrument was found to have a piece of epoxy layer missing over the distal end fibers and it is unknown whether epoxy fragments may have fallen into a patient.
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The endowrist sp camera was returned to intuitive surgical, inc.(isi) via the rma process and failure analysis was completed on (b)(6) 2019.Although the site did not express any complaint or concern regarding the instrument, failure analysis identified residual soil adhered to the tip of the camera and noted that there appeared to be a piece of epoxy layer missing over the distal end fibers of the instrument.Although there was no report that any residual soil made contact with a patient, this mdr is being reported because of the potential for a small piece of inert, benign-geometry epoxy to be retained inside a patient.
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