Model Number CYF-5 |
Device Problems
Device Reprocessing Problem (1091); Material Rupture (1546)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this case has been received by olympus for physical evaluation.The investigation is ongoing.The definitive cause of the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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Event Description
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It is reported during reprocessing of an oes cystonephrofiberscope, the scope was sterilized without the sterilization cap.As a result the bending cover ruptured.There was no patient contact/impact.
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Manufacturer Narrative
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This report is being updated to provided additional evaluation findings.The reported problem was found to be due to the device being sterilized without the sterilization cap.As a result the bending cover ruptured.This is a not reportable device malfunction and further investigation is not indicated.
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Search Alerts/Recalls
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