The incident device anticipated to return.A follow-up report will be provided upon completion of 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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Full udi# provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the latis pad was detached from the jaws.Upon further inspection, the remaining material on the jaw was even across the surface, indicating the adhesive was applied uniformly during manufacturing.The exact cause of the pad detachment is unknown; however, it may have been due to excessive force during surgical use.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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