After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that one-piece 14mm channel reamer instruments cannot be reprocessed as they cannot be thoroughly cleaned and corrosion cannot be removed.As this was noticed in the sterilization department, the finding did not affect any particular patient.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since there was not patient involvement; and therefore, there was no serious injury.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.
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