Medical Device or Device Component Failure to Unfold or Unwrap

Issue associated with the comprising materials' deformation in that a device fails to open its wrapping or open/extend to a certain fashion or form i.e. balloon or lens. (Food and Drug Administration)

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Medical Device or Device Component Dislodged or Dislocated

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

Medical Device or Device Component Damaged by another Device

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

Medical Device or Device Component Connection Issue

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

Medical Device Optical Issue

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

Medical Device Operational Issue

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…

Medical Device Operates Differently Than Expected

Issue associated with any deviations from expected performance while operating and using the device.