Model Number OER-4 |
Device Problems
Device Reprocessing Problem (1091); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that the facility connected the subject device and endoscope using the wrong connecting tube.There was no report of patient injury associated with this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.However, based upon the information from the user the reported phenomenon was attributed to the user mishandling.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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