Model Number CV-190 |
Device Problem
Poor Quality Image (1408)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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To resolve the reported problem, olympus technical support provided troubleshooting assistance via the phone.Upon deleting the photos to clear the memory, the reported errors no longer occurred.The reporter indicated that the likely cause of the reported problem "image freezing" was due to an accidental press of button 1 by the end user.
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Event Description
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A user facility reported to olympus that a "n207, images not transferred" error was generated and an "internal buffer full" error occurred.Additionally, it was reported that an intermittent freezing issue occurred.There was no patient injury or harm, associated with the problem, reported to olympus.
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Event Description
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The problem occurred after a procedure with no patient involvement.
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Manufacturer Narrative
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This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation determined the following possible causes: 1.) unintended use error due to the user inadvertently pressing the button set to freeze and 2.) a malfunction due to deterioration of parts of the image processing board.
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Search Alerts/Recalls
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