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 was unable to be cleared despite multiple troubleshooting steps taken in efforts to resolve the issue.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.Three (3) good faith efforts were made to retrieve the device without success.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.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c02073 was performed, which confirmed that there was one (1) non-conformance issued to this lot that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformances.The handpiece passed final inspection prior to release for distribution.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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