Model Number OER-PRO |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The endoscope service specialist (ess) observations include that the customer does not check the leakage tester before use and does not remove the scope completely from the water to disconnect the leakage tester.Some of the pre-cleaning steps are being omitted.The customer brushes while the suction is connected.The customer also needs care and handling in-services.The ess explained to the technician that the test strips must be used prior to every cycle that is run and that the machine should not be used until test strips are available.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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During a tiger team repair reduction, an endoscope service specialist (ess) noticed that the customer was not using test strips to check the mrc of the acecide-c.There was no patient involvement or injuries reported.No additional information has been obtained.
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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 investigation and to correct information provided on the initial report.A review of the device history record confirms the subject device was shipped in accordance to specifications.Based on the results of the investigation, the phenomenon occurred because the operator did not conduct the proper reprocessing procedure.The instructions for use confirms verbiage identified to prevent the phenomenon within chapter 3 inspections before use, section 3.10 checking the disinfectant solution concentration level: "prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life".
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Search Alerts/Recalls
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