Model Number URF-P6 |
Device Problems
Mechanical Problem (1384); 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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Customer reported with an issue of curve rubber air leak.The issue found during an unknown event.There was no patient harm or injury reported due to the event.No user injury reported.Device evaluation found the insertion tube (a-rubber) has fallen off.
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Manufacturer Narrative
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The subject device was evaluated.Device inspection found leak on bending tube (curved rubber).The customer reported issue was confirmed.In addition, service repair noted the insertion tube (a-rubber) has fallen off.The bending angle is insufficient due to the elongation of the angle wire.The ig (image guide) bundle is significantly broken due to external factors.There is a strange noise when operating the angle.The (up/down) ud angle fixing lever (sp) is cracked.There are scratches on the eyepiece, angle lever due to external factors.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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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 final 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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to external factors or handling.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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