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Model Number A22001A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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It was observed during the device inspection, that the hysteroscope had a missing direction pin.There were no reports of patient involvement.
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Manufacturer Narrative
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The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Additional information added to fields h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Based on the results of the investigation, the error patterns detected indicate a cause due to excessive force.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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