The device has not been returned to olympus medical systems corp.(omsc), but was returned to olympus repair center for evaluation.The evaluation of the device by olympus repair center confirmed the following: the image sensor unit and the bending section rubber of the device was defective.A part of the adhesive of the bending section rubber was missing.The image sensor cable had failure insulation.Omsc reviewed the manufacturing history (dhr) of the device, and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined, however there is possibility that the reported event was caused by breakage of the image sensor, defect of the circuit board inside the video connector or of the video system center connected to the device.If additional information becomes available, this report will be supplemented.
|