The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of probe cover holes was confirmed but the exact cause is unknown.One probe cover was returned with a drape in open packaging.The packaging label information showed lot: redq0766.Acoustic gel was present within the probe cover.A tear was observed 0.7 cm from the distal end of the cover.The tear was longitudinal and 2 cm in length.Microscopic observation of the tear revealed the edges to be uneven with points of material elongation.Based on the condition of the sample returned, possible contributing factors include damage during assembly of the device and excessive force applied during use.The product instructions for use (ifu) states, "caution: always snap the needle guide on to the probe hook.Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear." a lot history review (lhr) of redq0766 showed no other similar product complaint(s) from this lot number.
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