An investigation was completed as the actual device was returned to the (b)(4) facility on 07/02/2015.The brushing that fell into the patient had laser damage completely through, splitting it.The busing was then able to be squeezed smaller than the working channel and fall out of the device (see attached photo).The objective head of device also took a strong laser hit and vertebrae was broken in two places.Above damage indicates user error during the handling of the device.Device was purchased new on (b)(6) 2014.Request for add'l info sent to initial reporter.No response as of 07/24/2015.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.(b)(4) considers this matter closed.However, in the event we receive add'l info, we will provide fda w/follow-up info.See scanned page.
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