User facility medwatch report received indicates that when the orthopedic hand surgeon took the scope out and put it back into the patient's wrist, he could not see very well.Scope was sent out for evaluation and repair.Facility biomed examined the scope and noted that the tiny glass/clear cover that goes over the lens, was missing.Md was notified and disclosure was done with the patient.Md to continue to follow up with the patient.Md determined the piece is so small it would not be able to be located/noted on x-ray and more than likely would have been washed out of the patient during copious irrigation that took place during the procedure.There have been no complaints of pain/issues from the patient.
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Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.Evaluation codes updated to indicate that manufacturing review was performed.(b)(4).
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