It was reported that there was an issue with bb542 - carbon steel scalpel blades #12d.
According to the complaint description, it was reported that the blades broke inside patient's mouth and remained in the gum.
Additional information received, that three scalpel blades of the mentioned type of it happened that the tip of the blade broke off during a standard operation ("unfolding").
The broken off parts were about 0.
5mm to 1mm long.
There were no patient injuries, i.
E.
Up to now such injuries are not known.
However, it can not rule out the possibility that further splinters of the blades may be discovered in future x-rays.
The adverse event / malfunction is filed under aag reference (b)(4).
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