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Model Number GF-UCT180 |
Device Problem
Failure to Clean Adequately (4048)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the up/down knob could not be locked securely due to wear of the forceps elevator lever, water tightness was lost due to deformation of the electrical connector guide pin, the displayed ultrasound image was defective with missing elements due to damage on the ultrasonic probe, the distal end was deformed, the bending section cover adhesive was worn, and the bending angle in the up direction did not meet the standard value due to wear of the angle wire.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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Event Description
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The customer reported that air insufflation via the valve of the evis exera ii ultrasound gastrovideoscope did not work.Several valves were tested during the procedure.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found foreign material exiting the air/water nozzle and distal end.The report is being submitted due to foreign material found during evaluation.
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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, the foreign material could not be identified nor the root cause of it.The event can be detected/prevented in accordance with the following instructions for use: chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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