This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the specific complaint device could not be reviewed as the serial number could not be provided.Olympus ensures all devices meet all design and quality specification before shipping.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: 3.1 the workflow of preparation and inspection the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5,"troubleshooting".If this endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, "returning the endoscope for repair".Conclusion: the definitive cause of the user's experienced cannot be determined.No device issue was identified.It is possible that the reported event may have occurred due to the handling of cyf-vhr or to the site of the lesion when cyf-vhr was used.
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