A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during jet alignment, the aquabeam robotic system generated an "e22 - motorpack error" message.Aquabeam robotic system generated an "e22 - motorpack a second aquabeam handpiece was used and again, the aquabeam robotic system generated an "e22 - motorpack error" message.A third aquabeam handpiece was used which resolved the issue.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 an investigation into the reported event.No visual defects or anomalies were observed with the handpiece.Functional testing confirmed the reported event.The handpiece was deconstructed and viewed under magnification.Signs of excessive fluid ingress were observed as salt deposits on the encoder wheel and sensor board can be seen.It is unknown how the fluid entered the handpiece.The root cause source is undeterminable as it is unknown how fluid entered the handpiece.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c05214 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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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