(b)(4) 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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Investigation summary: the event unit was returned for evaluation.Upon visual investigation, engineering noted that the unit was returned with no clips, including the lockout clip, and the lockout had been broken through.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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