Model Number GF-UCT180 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
malfunction
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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 (b)(4), it was found that the ultrasound probe and acoustic lens has gap, the glue was missing.The subject device had been returned to the (b)(4) for repair of the leakage.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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The subject device was inspected at (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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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.Since multiple damages were confirmed at the distal end, it is possible that an external force was applied to the distal end, but the cause could not be identified.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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