A review of the device history record (dhr) serial number (b)(4) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(4), which confirmed no other similar events have been reported on this system.A review of similar events on all other systems confirmed 4 other similar events.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.D, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.As the product was not returned for investigation, a root cause for the reported event could not be determined.Bleeding is a potential risk of the aquablation procedure.Based on the review of the information received by the treating physician, a review of the dhr and ifu, the event is considered not to be device related.
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A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-aquablation procedure the patient received a blood transfusion (number of units unknown) due to a decrease in hemoglobin levels (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).The treating physician confirmed that the blood transfusion was not attributed to the aquablation procedure, but rather to the patient's pre-operative condition.The patient was reported to be in good condition.No further information was provided.
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