The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.A review of the operations service manual found the following warnings and precautions the wand is supplied sterile.The wand is intended for single use only.Do not clean, resterilize, or reuse the wand as this may result in product malfunction, failure, or patient injury, which may also expose the patient to the risk of transmitted infectious diseases.Please refer to the instructions for use associated with each wand type for specific information concerning wand use.Error: controller powered on with re-used wand.E8: wand error a relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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