A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure, the aquabeam robotic system generated an "e22 - motorpack error" message, which could not be cleared despite multiple troubleshooting steps taken in an effort to resolve the issue.A second aquabeam handpiece was used, which successfully resolved the issue, and the aquablation procedure was completed successfully.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.
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The aquabeam handpiece was returned for investigation.Visual inspection of the returned device revealed no physical damage or anomalies.Functional testing of the device could not confirm the reported event.The handpiece was deconstructed and viewed under magnification.No signs of fluid ingress were observed on the sensor board and the encoder wheel.The root cause of the reported event is undeterminable as the handpiece functioned as intended.The aquabeam robotic system's treatment logs file was reviewed which confirmed the reported event.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c03114 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 reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.Table 5 system detected errors and faults e22 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.E23 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece e50 - console error release foot pedal and click x.If error persists, turn off and turn on console and cpu submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.
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