Model Number LF-DP |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was observed that during the device evaluation, the insertion unit flexible tube coating peeling off the flexible scope.There were no reports of patient involvement.
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Manufacturer Narrative
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The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: b5 (common device name corrected).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over thirteen (13) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: it is presumed that the defect was caused by stress of repeated use, external factors, or handling.The event can be detected by following the instructions for use which state: the instruction manual ¿chapter 3 preparation and inspection, 3.2 preparation and inspection of the endoscope¿.Olympus will continue to monitor field performance for this device.
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Event Description
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It was observed that during the device evaluation, the tracheal intubation fiberscope coating peeling off the flexible scope.There were no reports of patient involvement.
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Search Alerts/Recalls
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