Model Number GF-UCT180 |
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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Manufacturer Narrative
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The subject device was received and evaluated.Device evaluation found glue defects around the forceps cover, and the pink probe was found loose, minor peeling of glue on the edge of the probe not exposing the glue underneath.Peeling on a-rubber glue (bending section) was noted.Furthermore , multiple squash found on insertion tube and w-mouth piece was observed to be loose.Control knob was found with play.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, the device bending section of scope has been pinched/kinked.The issue found during reprocessing.There is no patient involvement associated with this reported event.No user injury reported.Device return evaluation found glue defect around the forceps cover , minor peeling of the glue on the edge of the probe.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation.A correction to g2 to add foreign country name.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 definitive root cause of the reported event could not be determined.According to the following investigation results, there were scratches around the area pointed out; therefore, we cannot rule out the possibility that some kind of external force was applied to the relevant part.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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