Device returned for evaluation.Returned to manufacturer on 1/8/2018.Device evaluation completed 1/11/2018.When jacket was visually inspected, no defects seen or felt other than a small amount of wrinkling of the jacket.No hole was observed as previously reported.When device flushed with water, no leaks seen and water passes normally.When calibrating, laser light seen about 7 inches from tip coming through the jacket although the jacket is not breached.Under microscope dark mark seen under jacket at said spot leading to the conclusion that broken fibers are present at that spot; dark mark present as an effect of heat at spot.As a result of device evaluation, this is not a reportable event.No reported patient harm; no breach to device jacket; no potential for injury with recurrence based on device evaluation.
|