The customer reported to olympus when the concentration was checked on six (6) endoscope reprocessors (model numbers oer-4 and oer-5), the concentration was determined to be a nanogram (ng), which was lower than expected.Additionally, foreign matter was detected on the oer water filter at the water supply hose attachment port.The customer suspects that there may have been an issue with the disinfectant that was used (acecide) or the water filter.According to the customer, the acecide concentration was checked on the third day of its use and the test strip was pure white.It¿s unknown how many times the oer-4 was used during this time but the customer reported normal usage was about five to ten times a day.Normally, the customer checks the concentration after five (5) days or after 16 times.The customer was checking the concentration in preparation for cleaning the scopes before a colon examination.The customer did not have any issues with the oer-3s onsite, even when checking the concentration on day six (6).It is unknown when the concentration of acecide first became ng and it¿s unknown if any scopes that had been reprocessed around this time were impacted or were used on a patient if impacted.There were no reports of patient harm associated with this event.Patient identifiers: (b)(6) (oer-4/sn (b)(4), (b)(6) (oer-4/sn (b)(4), (b)(6) (oer-4/sn (b)(4), (b)(6) (maj-2318), (b)(6) ( maj-2318), (b)(6) (oer-5/sn (b)(4), (b)(6) (oer-5/sn (b)(4), (b)(6) (oer-5/sn (b)(4), (b)(6) (maj-2317), (b)(6) (maj-2317) and (b)(6) (maj-2317).
|
This supplemental report is to inform, that upon further review, this is not a reportable malfunction.As it relates to the subject device (water filter).Which is a component of the oer endoscope preprocessor.Per the legal manufacturer, the risk of the disinfection concentration level being below specification is associated with the oer endoscope preprocessor.Therefore, the malfunction has been reported to the fda on the respective oer endoscope preprocessor medwatch.And this initial report is no longer applicable.
|