It was reported that during set up of an unspecified procedure, the operating room (or) staff noticed the x-stream controller would not function in the hi or lo setting and the led lights would not illuminate.The or staff used another controller for the case.There was no patient involvement.The device was sent to the biomed dept.With the same results.The subject product was returned to davol for evaluation and the evaluation identified that some internal components had heat damage with evidence of internal combustion having occurred.There was no report of a short circuit, smoke, or flame having occurred during use of the device.
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