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Sterility of the device is compromised due to lack of package integrity
The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.
The motor may fail to activate when the on/off switch is pressed.
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement
Firm found pinholes in packaging which would compromise sterility.