The warnings in the package insert state this type of event can occur.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.This is report 2 of 5 for the same event.Reports 1, 3-5 are reported on mfr #:0001032347-2016-00263, 0001032347-2016-00265 through 0001032347-2016-00267.
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(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.According to the product evaluation, the complaint is confirmed as the tip of the elevator is slightly bent.The most-likely, underlying cause of the complaint was determined to be excessive force.The instructions for use states, "the tip of the instrument is extremely thin and delicate; care should be taken to avoid applying significant pressure to the tip." the non-conformance database was reviewed in the product evaluation and no non-conformances were found for this lot.There is no indication of manufacturing defects.This is report 3 of 6 for the same event.Reports 1, 2, and 4 through 6 are reported on mfr # 0001032347-2016-00230-2, 0001032347-2016-00263-1, 0001032347-2016-00265-1 through 0001032347-2016-00267-1.
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