A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedural setup, the aquabeam scope was unable to latch into the aquabeam handpiece.A second aquabeam handpiece was opened, and after inserting the aquabeam scope into the aquabeam handpiece, the scope tip could not be retracted.As a result, a third aquabeam handpiece was opened, which resolved the issue.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient as a result of this event.
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The aquabeam handpieces were returned for investigation.No visual defects or anomalies were observed with the returned devices.Functional testing of the returned devices could not reproduce the reported issues, and the handpieces functioned as intended.Thus, the root cause is undeterminable.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c00937 was conducted, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformance.The handpiece passed final inspection prior to release for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup.An audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.Note: do not use excessive force to advance the aquabeam scope.If resistance is felt, gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure.Confirm the aquabeam scope is fully engaged by advancing and retracting the scope proximal key and observing the scope tube tip moving in concert with the aquabeam scope.With the proximal key fully retracted, align the scope carriage over the proximal key adapter.Attach to the aquabeam handpiece by pushing the scope carriage forward to engage with the carriage track.Retract the scope tube tip on the aquabeam handpiece to 1 inch (2.54 cm) in front of its fully proximal position.Using the knobs on the carriage, advance the aquabeam scope forwards (distal) and backwards (proximal) to ensure that the aquabeam scope is fully engaged with the aquabeam handpiece.The scope tube tip should move forwards and backwards in concert with the movement of the aquabeam scope.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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