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 07/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the f-r bands,30 procedure was installed by the physician after the expiration date advised.It was reported that the physician is replacing the device in question with a device that the expiration date has not expired.The customer was advised that after the expiration date of a product expires, package degradation could occur effecting the sterility of the device and device should not be used on a patient.There was no report of patient harm or user injury associated with this event.
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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.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 6 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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