Model Number SIF-Q180 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to olympus medical systems corp.(omsc), but was returned to olympus (b)(4) for evaluation.In the evaluation of olympus (b)(4) the following was confirmed; the reported event appeared to be caused by incorrect customer's handling.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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Foreign material exited from the biopsy channel of the device.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.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Omsc was informed that the foreign material that exited from the biopsy channel was a protective sleeve of the dilation balloon.And the user forgot to remove the protective sleeve when inserting the dilation balloon into the scope.Therefore, the reported event appeared to be caused by incorrect customer's handling of forgetting to remove the protective sleeve from the dilation balloon.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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