The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Based on the description of the event, it is likely that the incision size was not adequately enlarged prior to specimen removal, resulting in excessive force being exerted on the tip of the bag and causing the bag to tear.The instructions for use (ifu) states, "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal." it is also possible that a sharp instrument or object came in contact with the tissue bag, causing the bag to fragment during specimen removal.
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