Model Number MAJ-207 |
Device Problems
Product Quality Problem (1506); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not yet been received for evaluation.The root cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, at delivery acceptance during inspection, it was found the suction buttons were loose when installed on the scope and easy to fall off, it happened for all scopes.There is no patient involvement associated on this reported event.No user injury reported.
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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 g2 to add foreign country.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, it was concluded/assumed that the reported suction valves were within standard, but loosening torque was close to the tolerance limit due to variability in molding.In conclusion, a root cause could not be identified for this reported phenomenon.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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