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Model Number URF-P7R |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2024 |
Event Type
malfunction
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Event Description
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It was reported, the fiberscope had an image problem.There were no reports of patient harm.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the evaluation found, the image was blurry, the distal end plastic cover was cracked; the bending section cover was peeling and had hole/cut and the air/water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the image problem was a leak from the bending section cover glue and plastic distal end cove.This caused a malfunction of circuit, such as short circuit, caused by fluid invasion.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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