Pentax medical was made aware of a complaint that was noted in the operating room after the procedure in the (b)(6) region.The reported complaint "after using the scope, the surface of the lg prong produces high temperature.The lg prong wasn't isolated which caused the surgery placemat to be burnt and it could be the risk of fire." involving the pentax product, model fnl-7rp3.No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported.However, the information reasonably suggests that if the malfunction recurs while in use with pentax product is likely to cause or contribute to a death, serious injury, or other significant/important medical event as defined in 21 cfr 803, therefore this event is reportable.A dhr cannot be performed for this device since the serial number cannot be confirmed.
|