A male patient with a "massive" posterior diverticulum underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that while positioning the aquabeam handpiece in the patient, the diverticulum filed with saline, obstructing the bladder neck.As a result, the treating surgeon avoided treatment at the base of the prostate near the bladder neck and only treated the fossa.After aquablation therapy, the treating surgeon was unable to access the bladder with the resectoscope, requiring the use of a flexible scope and guidewire to place a catheter without focal bladder neck cautery.This resulted in inadequate treatment and for the bladder neck obstruction to remain.It was reported that twice after removing the catheter, the patient went into retention.The physician proceeded with transurethral resection of the prostate (turp) on (b)(6) 2024.No malfunction of the aquabeam robotic system was reported.
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The aquabeam robotic system is a reusable device; therefore, it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and instructions for use (ifu).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: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: urethral damage causing false passage or stricture, urinary retention.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The aquabeam robotic system instructions for use list urethral damage causing false passage or stricture and urinary retention as a potential risks of aquablation therapy.Based on the event details plus a 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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