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Model Number OER-PRO |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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The customer reported to olympus technical assistance center (tac), a scope was reprocessed with the endoscope reprocessor, after being used with black dye.It was noted, the scope was reprocessed twice and when scope was hung to dry, it was noticed, black dye was coming out of the distal tip.There was no harm or user injury reported due to the event.The scope that was reprocessed with the subject device is addressed in (patient identifier: (b)(6), serial number: (b)(4), model number: cf-hq190l) and a report will be submitted.
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Manufacturer Narrative
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The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and because the device wasn't returned for analysis, the definitive root cause of the reprocessing issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿always preclean each endoscope immediately after the examination.If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing.Failure to preclean will leave excessive amounts of debris adhering to the endoscope and may compromise the effectiveness of the reprocessing.It may also result in debris accumulating in the endoscope, preventing the endoscope from working correctly.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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