Medical Device Operates Differently Than Expected

Issue associated with any deviations from expected performance while operating and using the device. (Food and Drug Administration)

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Medical Device Model Family

A grouping of medical devices based upon model name or number.

Medical Device Misassembled by Users

Issue associated with the use of the device characterized by users' incorrect assembly of device components, parts or constituents.

Medical Device Mechanical Issue

Issues associated with any deviations from device documented performance specifications relating to mechanical defects, including moving parts or subassemblies, etc.

Medical Device Material Torqued

Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material

Medical Device Material Split

Issue associated with a partial or full-thickness crack in the device materials.

Medical Device Material Separation

Issue associated with an undesired disassociation or breaking apart of device materials.