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Model Number OER-6 |
Device Problem
Device Handling Problem (3265)
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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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There are four automatic endoscopy reprocessors (aers) at the facility impacted.There are also four water filters, one for each aer, associated with this event.As reported for this event by the facility, the water supply lines to the device were disinfected on the day the acecide disinfectant of the device was changed.The normal usage for of the acecide disinfectant for the facility was 27 times before the acecide was required to be changed.The facility did not do a check for the disinfectant concentration at every use of the device as recommended by the instructions for use.However, a disinfectant concentration check was performed for one of the aer devices the day after the disinfection of the water supply line, though the 27 uses were not completed, and the device failed the concentration test.There is a possibility that a scope was reprocessed with reduced concentration of acecide disinfectant and used.In addition, it was found that this was the first time the facility disinfected the water supply line since the aer devices were delivered approximately eight months before the event; the water filters of all four aers also had not been replaced since the first use of the device.The facility does not have any incident of harm reported to any patient or persons.The facility has now been made aware that the acecide concentration check needs to be performed for every use.
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Manufacturer Narrative
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Full name of the facility is (b)(6) hospital.There are total 9 devices associated with this event (four automatic endoscopy reprocessors (aers), four water filters, and one unknown scope).These devices are captured in medwatches with patient identifiers as below: patient identifier: (b)(6).Model #: oer-5 (aer).Serial #: (b)(4).Patient identifier: (b)(6).Model #: oer-5 (aer).Serial #: (b)(4).Patient identifier: (b)(6).Model #: oer-6 (aer).Serial #: (b)(4).Patient identifier: (b)(6).Model #: oer-6 (aer).Serial #: (b)(4).Patient identifier: (b)(6).Model #: maj-2317 (water filter).Patient identifier: (b)(6).Model #: maj-2317(water filter).Patient identifier: (b)(6).Model #: maj-2317 (water filter).Patient identifier: (b)(6).Model #: maj-2317 (water filter).Patient identifier: (b)(6).Model #: cf-h290i representing the unknown scope.This medwatch is for the patient identifier (b)(6).This device is not sold in the us but a similar device is.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
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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, the event likely occurred due to the user's lack of awareness and management method of disinfecting and replacing water filters.Information is stated in the oer-6 instructions for use (ifu) which may have prevented the event by following sections 3.11 checking the disinfectant solution concentration level, 7.3 replacing the water filter and 7.4 disinfecting the water supply piping.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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