Intuitive surgical, inc.(isi) received the endowrist sp camera involved with this complaint, and completed the device evaluation.Failure analysis confirmed the following customer reported complaint "distal tip inspection failure".For clarification, the camera was inspected, found the distal fiber epoxy to be broken, and dark spots at the distal tip.Additional findings not reported by the site: the distal window was found to be damaged with scratches.The cable light guide ferrule which is located at the connector was found to have water stains.The camera was placed on the in-house system and the camera failed during initialization, giving a communication error, and a temperature sensor error.A log review was performed as part of the failure analysis investigations, and related errors were identified.No image, or video was provided for review.No other complaints related to this event were reported.Based on the additional information provided at this time, this complaint is being reported due to the following: if an endoscope with a compromised epoxy layer is used on the patient, epoxy fragments could fall inside the patient.The endowrist sp camera distal tip was re-inspected and determined to have a piece of epoxy layer missing over the distal end fibers.At this time, it is unknown when the epoxy fragments may have fallen.While there was no harm, or injury to the patient, the reported failure mode could potentially cause, or contribute to an adverse event if it were to recur.
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It was reported that prior to the start of a da vinci-assisted surgical procedure, the endowrist single port (sp) camera failed distal tip inspection.The endoscope was replaced, and the issue was resolved.The procedure was being completed as planned with no reported injury.
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