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Model Number A22040A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated.And the customer¿s allegation was confirmed, due to there being no ceramic tip.In addition, the sealing ring was damaged.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the root cause of this phenomenon could not be identified.The likely cause of the broken ceramic tip, was wear and tear and/or improper handling by the customer.Investigation activities have been opened to manage actions related to this report and any required mdr reporting.Olympus will continue to monitor the field performance of this device.
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Event Description
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The customer reported to olympus, that when using an inner sheath, for 26 fr.Outer sheath, the ceramic tip was broken.The issue occurred during preparation for use.And the diagnostic procedure (general examination) was completed with a similar device.There was no patient under sedation at the time.No procedural delay.Or no patient harm associated with the event.
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Search Alerts/Recalls
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