(b)(4).Post market vigilance (pmv) and concurrently with engineering led, an evaluation of five trocars with fixation cannula opened by the account.Visual inspection noted the five obturators were received heat damaged.The tops of the obturators were not seated properly.Functionally, the condition of the instrument precludes functional testing.Replication of the observed heat damage may occur if the instrument is subjected to excessive heat during a sterilization process.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
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