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.Multiple troubleshooting steps were performed in an attempt to clear the error message; however, the error message persisted.A second aquabeam handpiece was used which resolved the issue and the aquablation procedure was successfully completed.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 not returned for investigation of the reported event.A review of the device history record (dhr) for aquabeam robotic system / serial number: (b)(6) and the aquabeam handpiece / lot number: 23c04638 was performed, 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 failure.The lot was segregated and affected units were reworked and re-inspected as part of our handpiece final inspection process.Upon re-inspection, the lot met all required specifications and was deemed acceptable to be released for distribution.The current user manual, sj-um0101-00 rev.B aquabeam robotic system user manual, states the following: 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.The root cause of the reported event was unable to be established as the device was not returned for investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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