Medical Device or Device Component Quality Issue

Issue associated with the comprising materials' deformation in that a device fails to open its wrapping or open/extend to a certain fashion…

Issue associated with mechanical force that displaces device and/or device components from an intended location.

Issue associated with one device and/or device component causing harm to another device and/or component.

Issue associated with linking of device and/or device components and/or the functional units set up to provide means for a transfer of…

Issue associated with problems transmitting visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the…

Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective-measure, and incompatibility…