This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based on the reported information, omsc surmised that the reported phenomenon was attributed to the following.- there was a difference between the brushing method for the forceps elevator performed by the user facility and the brushing method recommended by the instruction manual.- the staff of the user facility had not been trained sufficiently on the handling of the subject device, the reprocessing of the subject device after repair, or the usual reprocessing, following to the instruction manual.If additional information becomes available, this report will be supplemented.
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