Model Number UHI-4 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
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Event Description
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During a procedure, the alarm sounded and the indicators on the front panel went out when the user turned on the device.Other detailed information was not provided.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.The device was not returned to olympus medical systems corp.(omsc) for evaluation.Based upon evaluation on the similar events, omsc concluded that the pressure sensor on the main circuit board of the device was damaged accidentally.The manufacturer of the pressure sensor has concluded that the sensor's failure was attributed to a manufacturing process and the process was corrected.The failed sensor in this event had been manufactured before the correction was implemented.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The instruction manual of the device states the corresponding method in case of an abnormality.
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Search Alerts/Recalls
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