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Model Number FRB-30 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
Event Type
malfunction
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Event Description
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As reported for this event by the customer, the device (fallopian ring) placed in the patient had expired 12 days prior to the procedure.There was no issue in the completion of the procedure.There is no harm or adverse impact to the patient.
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Manufacturer Narrative
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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.Correction to h4, information was inadvertently not included on the initial medwatch.Three attempts were performed to obtain additional information, but no response was received from the customer.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.It has been over 3 years since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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