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 fuzzy ultrasound image was confirmed.There was interference observed in the ultrasound image.The root cause was identified as use-related damage to the metal strain relief of the probe.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and discarded at the service facility.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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