Model Number UHI-4 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned to omsc for evaluation but was returned to (b)(4).(b)(4) checked the subject device and found the reported phenomenon.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of olympus (b)(4), it was found that there were a lot of oily corrosions on the main board, the electropneumatic proportional valve, the manifold unit and the tubes inside the subject device.The subject device had been returned to (b)(4) because the front panel had damage.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause of this phenomenon could not be identified because the product was not returned.The corrosion may be attributed to usage and storage environment.The phenomenon seems to have occurred due to the user¿s handling.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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