The returned (b)(4) flexible video scope serial (b)(4) was received for evaluation due to "severe damage to insertion portion.Wires exposed".Visual inspection was performed on the received condition and determined that the insertion tube is severely broken below the protector boot which caused the metal coiled mesh to break exposing protruding sharp metal mesh.It was determined that the insertion tube is a non-olympus repair.Based on the device evaluation the cause of the damage to the non-olympus insertion tube is attributed excessive stress and force attributed to mishandling.As a precautionary measure, the instruction manual states the following; ¿do not twist or bend the bending section with your hands¿.Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.
|