(b)(4).Temporary damage that will heal fully and will most likely not negatively influence the patient in the future.Visually, no deviation can be found on the provided components.The recommended maintenance date 02/2019 is labelled on the handle and all components of the shaft.Vigilance investigator carried out the pictorial documentation visually and microscopically.A functional test was carried out and the applied clips found to be uneven.The jaw parts of the shaft are slightly bent and no longer even, most likely caused by a leverage effect during handling or reprocessing, tilting in a reprocessing basket.Additional damages on the cartridge were found, pressure marks, most like caused by a forceps, a crack at the distal end and scratching marks.The cause of this damage is no longer traceable.Three clips remained in the cartridge.No deviations can be found on the handle.The device quality and manufacturing history records have been checked for the available lot number and found to be according to specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage.
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