The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
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The event unit was not returned for evaluation.In the absence of the subject device, it can be difficult to determine the root cause.Applied medical issued a voluntary class ii recall on the ca090 direct drive clip applier due to increased customer feedback indicating inconsistent clip application, which has the potential to lead to unoccluded vessels.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
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