A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-procedure, the patient was later taken back to the operating room due to bleeding, which was addressed by clot evacuation and cauterization (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).No adverse health consequences were reported with the patient due to this event.No malfunction of the aquabeam robotic system was reported.
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Procept biorobotics received additional information that the patient was discharged from the hospital on (b)(6) 2020.The patient was reported in stable condition.No transfusion or other medical intervention needed with the patient.A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review for similar complaints was performed on serial number (b)(6), which confirmed that there were no other similar events reported on this system.There are four (4) similar events that have been reported across all systems.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.A, was reviewed and states the following: contraindications do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.In addition, do not use the system in the following: unable to safely stop anticoagulants or antiplatelet agents perioperatively.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding a root cause for the reported event could not be determined as the product was not returned for investigation.Bleeding is a potential risk of the aquablation procedure.Based on the review of the log file, dhr and ifu, the 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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