H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection found marks in the tube (clamp mark).Thus, the customers reported problem was confirmed.According to the tests carried out, the investigation showed that the mark originated when the clamp was activated.Based the analysis the root cause of the problem is the clamp was closed or manipulated during manufacturing process causing the pinch marks found in the tube and production personnel did not detect the damage of the unit.For corrective action an awareness notification was issued to production personnel to explain the importance and reinforce the adherence in procedure.The root cause of the reported problem was traced to the manufacturing process.
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