Model Number CV-180 |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for evaluation.According to the evaluation, the following was found.Olympus repair center could confirm the reported phenomenon.Video connector socket had a failure.Printed-circuit board had a failure.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.
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Event Description
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The user found that a color bar was sometimes displayed and the endoscopic image was flickering when the user turned on the power.This event occurred due to the cable.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The device was returned to olympus repair center, but not returned to olympus medical systems corp.(omsc).Therefore, omsc could not confirm the device.Olympus repair center found the malfunctions of the receptacle unit and print board.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.This phenomenon attributed to the failure of the receptacle unit and print board.The device was manufactured over 12 years ago.However, this phenomenon had occurred within 10 days from the device delivery date.The exact cause of the reported event could not be conclusively determined.Omsc surmised that the user might have purchased a secondhand defective receptacle unit and print board.
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Search Alerts/Recalls
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