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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Corrections: full udi number added.Investigation summary: a reusable probe was returned for evaluation.Upon investigation, engineering found that the event unit functioned as designed when it was assembled with the sterile valve and tubing.There was no apparent leaking.The root cause of this event is likely due to probe cap design.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this continuous process, applied medical has improved the design of the probe cap to minimize the potential for this type of event to occur.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.
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