A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-procedure, the patient was taken back to the operating room due to bleeding at the mid-prostate location, which was addressed by 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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A review of the device history record (dhr) for serial number (b)(6) 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)(6), which confirmed that there were no other similar events reported on this system.A review for similar events across all systems confirmed three (3) other similar events.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.A, was reviewed and states the following: 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 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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