Model Number MAJ-1080 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Event Description
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As reported for this event by the customer, during preparation for use the device o-ring cracked and fell off the yoke.There is no patient involvement and no harm reported to any patient.
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Manufacturer Narrative
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The customer ordered a replacement part to fix the issue.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
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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 root cause of the reported event is unable to be determined.However, the cause of the event is likely due to normal wear and tear or customer's handling.If additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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