The subject device was not returned to omsc for evaluation but was returned to omsi.Omsi checked the subject device and found the reported phenomenon, and also surmised that this phenomenon was attributed to insufficient cleaning by the user.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection of the subject device for repair at olympus medical systems (b)(6) (omsi), it was found that there was foreign material around the forceps elevator of the subject device.The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
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This supplemental report is being submitted to provide additional information.The correct date of "g3: date manufacturer received" is "september 22nd, 2021", not "september 21st, 2021" as reported in the initial report.The subject device was returned to olympus medical systems india (omsi).Olympus medical systems corp.(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 upon the information from omsi and similar past cases, omsc surmised that this phenomenon was attributed to the following.- the reprocessing around the forceps elevator after the procedure was insufficient.- since the user did not perform the reprocessing immediately after the procedure, the foreign material adhering to the forceps elevator dried and remained.The instruction manual of the subject device states appropriate reprocessing method.If additional information is received, this report will be supplemented.
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