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Model Number CYF-VH |
Device Problem
Device Reprocessing Problem (1091)
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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 and inspection, service repair noted the following findings: inspection found the adhesive of the distal end/bending section was separated, a-rubber was peeling, distal end rotation, insertion tube was buckled and there was deterioration of the resin, and insulation failure of the insertion section.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 has been sterilized without the security key.The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.
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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 cause of the device sterilized without the security key likely occurred from human error.However, a definitive root cause could not be determined at this time.The following information is stated in the instructions for use (ifu): "attach the sterilization cap (maj-1538) to the venting connector of the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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