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Model Number 744000 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device asset return was received and evaluated.Inspection found faulty pkrf board that will cause output issue.In addition, the base plate and front panel have dents can use as is.Faulty pkrf board was replaced , device was tested and passed per required testing and specifications.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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During an asset return inspection, faulty pkrf board was observed.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.The dhr was unable to be reviewed as the subject device was repaired multiple times.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.It has been over 17 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the faulty printed circuit board could not be determined at this time.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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