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Model Number OER-4 |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported to olympus that it was possible that an unknown scope model was reprocessed after it was discovered that the water filter of the olympus endoscope reprocessor (oer-4) was replaced every two months at the facility's discretion and the replacement deadline had passed.It was unknown if the scope was used clinically after reprocessing.There were no reports of patient harm.
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Manufacturer Narrative
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To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Pre-cleaning was completed immediately after the procedure and involved aspiration of water through the instrument/suction channel with a suction pump.The air/water channel was flushed with the air/water channel cleaning adapter.Manual cleaning was done after the procedure.The scope passed a leak test.Super flash detergent manufactured by adachi was used for manual cleaning.The instrument/suction channel, suction channel, and instrument channel port were brushed during manual cleaning.Manual disinfection was not done.An olympus oer-4 automatic endoscope reprocessor (aer) was used with endoquick as the detergent and acecide as the disinfectant.There were no defects with the aer.All channels were connected with tubes when setting up the aer, the concentration and expiration of the disinfectant was controlled, the disinfectant met the minimum effective concentration, the water quality was controlled.The water filter was not replaced in accordance to the instruction for use (ifu).The scope was dried using a clean towel and then stored in a cabinet without drying function at room temperature and normal air concentration.
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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, a definitive root cause of the reported oer-4 water filter not being replaced in accordance with the ifu could not be determined, however, the issue was likely due to the facility/user not reading or following the instruction manual carefully, resulting in mismanagement of the water filter replacement.The event can be detected/prevented by following the instructions for use which states: chapter 7: tasks to be performed monthly or weekly as needed 7.2 replacing the water filter (maj-2318) to prevent contamination of the rinse water, replace the water filter regularly, at least once a month.Also, replace it if an error code [e01] is displayed due to insufficient water supply.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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