The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: found during evaluation of original file: the ultrasound image is dark on the right side.This is due to a knick in the rubber on the probe end which is use-related h3 other text : evaluation findings are in additonal manufacturer narrative.
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