Medical Device Output Issue

Issue associated with any deviation from device documented performance specifications relating to the end result, data, or test results provided by the device. (Food and Drug Administration)

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Medical Device or Device Fragments Remain in Patient

Issue associated with the inability to retrieve device and/or device fragments during medical procedures.

Medical Device or Device Component Quality Issue

Issue associated with an inherent device and/or device component characteristic that is not satisfactory as specified or delivered.

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…

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…