A thorough evaluation of the x8-2t model transducer identified extensive damage to the device.Initial visual inspection noted the tip shell had scrape marks and appeared melted.Protein build up, discolored cable and knobs, worn i-tube and a wrinkled array window were also evident.The evaluation concluded the appearance and condition of the tip shell would not have been caused by the insertion or use within a patient and would have been present prior to use.The exact cause of the damage could not be determined, however, philips concludes that this is not a manufacturing or design based defect and is indicative of improper maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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