The subject device was not returned to olympus medical system corp.(omsc).Therefore, omsc could not evaluate the reported device.The exact cause of this issue could not be conclusively determined.Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, it is assumed that the event did not occur due to malfunction of the device, but occurred as a general accidental symptom of the procedure.
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