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: the device was returned to the service facility for evaluation.During evaluation, the reported issue of cracked probe was confirmed.The pad on the face of the 20mm gt probe has multiple cracks in it, causing black lines in the ultrasound image.The root cause is use related damage.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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