The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation by omsc, the reported endoscopic image loss was not duplicated.The evaluation confirmed a leakage from the instrument channel of the device.In addition, it was confirmed that there were multiple peels on the inner surface of the instrument channel.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Considering the evaluation result, it was surmised that the reported event occurred by short circuit around the electrical image unit (ccd) due to water invaded through the leakage of the instrument channel.The leakage of the instrument channel was possibly caused by interference of endo therapy accessories.The instruction manual of the device instructs; be sure to perform a leakage test on the endoscope prior to manual cleaning, and do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism or other malfunctions and poses an infection-control risk.
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