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Model Number OER-PRO |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to olympus for evaluation.During troubleshooting, it was observed, the customer was instructed to drain the disinfectant and was able to get the bottles out and reload the disinfectant without error.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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Event Description
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The customer reported to olympus technical assistance center (tac), during preparation for use, the bottle of the endoscope reprocessor jammed in the disinfectant drawer after the user attempted to load disinfectant in the reprocessor.There was no harm or user injury reported due to the event.
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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, it is possible that the jam was caused due to the drawer being closed without properly installing the bottle.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿if any irregularity is detected during an inspection or if the device is clearly malfunctioning, do not use it.Contact olympus for repair.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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