The subject device and concomitant the ltf-s190-10 were returned to olympus for evaluation.Olympus confirmed the subject device worked properly.Olympus could reproduce the phenomenon when the subject device was connected to the ltf-s190-10.The subject device detected ccd over current when the ltf-s190-10 was connected to the subject device.Therefore, the ltf-s190-10 might have some malfunctions.Olympus also checked the device history record of the subject device, and there was no irregularity found.There were no further details provided at this time.If significant additional information is received, this report will be supplemented.Please cross reference the associated complaint files: mfr report#: 8010047-2016-00231.
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The monitor image was lost when the user facility inserted the endoeye flex deflectable videoscope ltf-s190-10 to the patient's body cavity.The user facility turned off and on the subject device, and disconnected and connected the video connector to the subject device.However, the phenomenon still occurred.The facility completed the procedure with replacing the videoscope to another videoscope.There was no report of patient injury in this event.
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