Additional information requested and received.No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.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 product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records showed that this lot passed all manufacturing and quality standards.All graspers undergo 100% visual and functional inspection during the manufacturing and assembly process.The root cause of the event could not be confirmed; however, it is possible that user exerted high amounts of force when using the grasper.It is important to note the potential complications associated with the use of graspers, as stated in the instructions for use (ifu), include, but are not limited to: local trauma, injury, and tissue necrosis.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 21 cfr 803.56, if additional information is obtained 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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