This supplemental report is being submitted to provide additional information.The subject device was not returned to omsc for evaluation, therefore omsc could not investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However based on the information from olympus india, there was the possibility that this phenomenon was attributed to the malfunction of the electrical circuit board the pressure sensor mounted, which might be caused by the aging degradation of the subject device due to long term use.If additional information becomes available, this report will be supplemented.
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