Model Number CYF-V2 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2022 |
Event Type
malfunction
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Event Description
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The customer reported that the outside layer was coming off the working channel of the subject device.The issue was observed when they were preparing the device for use.There was no patient or user injury reported due to the event.Additional details were requested regarding the reported event.At this time, no additional information has been provided.
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Manufacturer Narrative
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The subject device was returned to an olympus service center for evaluation.During inspection and testing, service found the outer covering of the insertion tube was peeling off.In addition, the image was observed to be flickering.The labels were found worn and peeling.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Manufacturer Narrative
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This report is being submitted to provide the results of the legal manufacturer's investigation not included on the previous report.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.The investigation results could not determine, the specific root cause at this time.Olympus will continue to monitor field performance for this device.
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Manufacturer Narrative
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This supplemental report is to inform that upon further review, this is not a reportable malfunction.The legal manufacturer's investigation found, that there was no foreign material coming off the working channel, only the metal was exposed.The metal exposure from the serpentine at the insertion section may have occurred, due to stress or handling or other factors.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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