A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 4 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it is likely the angulation got locked due to internal flooding caused by a leakage which resulted in corrosion of the internal metal.However, a definitive root cause could not be determined.The reported issue (pinhole) was confirmed and found to be caused by external factors.It was observed there was a leakage due to perforation of the forceps channel.There was water invasion in the light guide bundle, the control section was corroded due to a leakage, the inside of the light cover glass was corroded, and the switch button #4 had poor contact.There was a leakage on the grip, the up down plate, the universal cord, and the light guide connector due to handling.Scratches were observed on the grip, the up down plate, the universal cord, the light guide connector, the rotating mechanism, the insertion tube protector, the angle lever, the video cable, the video connector, the video connector case, and the up down angle fixing lever due to external factors.Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
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The customer reported there was a pinhole on the subject device.No procedure was affected.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.During inspection and testing, it was observed the angulation was locked.This report is being submitted for the malfunction found during evaluation (angulation locked).Additional details were requested regarding the reported event; however, no further information was available.
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