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 "e42 - motorpack error" message.The aquabeam cpu and aquabeam console were restarted, 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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H.3 device evaluation by manufacturer: the aquabeam handpiece was not returned for investigation.The treatment log files could not confirmed the reported e42 - motorpack error but observed e22 - motorpack error and e23 motorpack error messages.However, how or what triggered the observed errors was unable to be established without the physical inspection of the device.A review of the device history record (dhr) ab2000-b/ serial number (b)(6) and the aquabeam handpiece/lot number 23c01900 was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.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.E42 - motorpack error release foot pedal and click x.If error persists, reconnect motorpack to console and turn off and turn on console.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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