Subsequent investigation into this event concluded that the rectal perforation was likely caused by the physician exerting excessive upward pressure of the trus probe on the anterior rectum.This was confirmed by ultrasound images that showed the prostate being wrapped around the probe.The posterior-most aspect of the prostate could not be seen, consistent with excessive force being applied.The aquabeam system's instructions for use (ifu), ifu320301, rev.D, lists rectal perforation as a potential perioperative risk of the aquablation procedure.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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