The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
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Olympus (oekg) was informed that the customer endoeye flex 3d deflectable videoscope has ¿leakage and dropout of image¿.The customer reported problem occurred at the end of the procedure, the image dropped out for a few seconds and immediately came back up again.No equipment was replaced as the procedure was completed using the same scope and equipment.Following the procedure, during reprocessing the device was inspected and leakage was found.No death or injury was reported to olympus.
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The evaluation was completed.During device evaluation, the phenomenon was not reproduced.As there are no abnormalities as well as in appearance, we could not determine the cause of the phenomenon based on the investigation result.Additionally, there was a control section leak, a-rubber glue lifted, video cable kinked, universal cord wrinkled; however, these defects are not considered severe enough to cause a potential adverse event.No evidence of fluid invasion was found in the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The following information is stated in the instructions for use (ifu): ¿important information ¿ please read before use: dangers, warnings, and cautions: turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor.Important information ¿ please read before use: precautions for disappeared or frozen endoscopic image: do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connectors, and light guide connector.The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result.Before connecting the video connector to the video system center, confirm that the video connector, including the electrical contacts, is completely dry and clean.If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and video system center may malfunction.If air bubbles emerge from the endoscope continuously during leakage test, do not use the endoscope.Water may enter the endoscope and cause a short circuit.This may result in breakage of the switch and image sensor.¿ olympus will continue to monitor field performance for this device.
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