A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware post-aquablation procedure the patient was taken back to the operating room (or) due to bleeding.The patient underwent additional cauterization to control the bleeding, which was identified to be coming from the mid-anterior prostate.The patient was reported to be in good condition.No malfunction of the aquabeam robotic system was reported.Per the manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure.
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H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information reported to procept, plus a review of thedevice history record (dhr) and labeling.The treatment log files were not available for review.A review of the device history record (dhr) ab2000-b / serial number (b)(6) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: the aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3 warnings: procedure: · as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The device was not returned for investigation because it performed as intended during the aquablation procedure.The aquabeam robotic system instructions for use list bleeding as a potential risk of the aquablation procedure and provide adequate instructions on how to achieve appropriate hemostasis.Based on the review of the information provided, plus a review of the dhr and ifu this event is considered not to be device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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