Model Number CV-180 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during preparation for use of the subject device, the endoscopic image of subject device was not displayed.The service department of olympus china checked the subject device and found the abnormality of the endoscopic image.There was no report of patient injury associated with this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause could not be determined because there was no delivery of the subject device.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus china (repeatedly resetting of the image by insufficient driving) there was the possibility that the reported phenomenon was attributed to the failure of the patient circuit board due to the deterioration of the components by repeatedly long-term use because over nine years had passed from the subject device had been manufactured.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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