The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.In the evaluation of omsc the following was confirmed; the reported phenomenon was not reproduced.The subject device was disassembled and investigated, but there was no problem inside the subject device such as water ingress, failure of soldering and wiring.However when the electrical circuit board with the condition disassembled the subject device was heated, the endoscopic image disappeared occasionally.Therefore omsc identified that this phenomenon was attributed to the electrical component failure of the electrical circuit board.The exact cause of the electrical component failure could not be conclusively determined, however there was the possibility the cause of the electrical component failure might be the deterioration, overcurrent or static electricity.If additional information becomes available, this report will be supplemented.
|