Other text: additional event information received indicating no patient involvement.H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: three used samples and one additional part were received without their original packaging, with their certificate of safe handling and their obturator.Lots of each sample are referenced in the dhr review section.Visual inspection results: during the inspection, no discrepancies were found.Functional test: the 4 samples received were inflated with air using a 5 ml syringe, after that the cuff were gently manipulated.Each cuff was inflated without abnormalities.It was demonstrated that the cuffs were symmetrical, and no leak was detected.No corrective actions required since the complaint was not confirmed.The customer stated problem was not duplicated.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.No information provided to date.
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