Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report number 3012447612-2018-00153.The subject inserter and shaft were used in three procedures within the same hospital with the same outcome prior to manufacturer notification.The inserter is the subject of reports 3012447612-2018-00152, 3012447612-2018-00198, and 3012447612-2018-00200.The shaft is the subject of reports 3012447612-2018-00153, 3012447612-2018-00199, and 3012447612-2018-00201.
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Additional information in lot number.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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