A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the second treatment pass, the aquabeam robotic system generated an "e22 - motorpack error" message.The prompts were followed in order to clear the error.The treating surgeon attempted to complete the second treatment pass; however, the aquabeam robotic system generated an "e22 - motorpack error" message.The treating surgeon decided to move forward to the focal bladder neck cautery portion to complete the case with a reported "great" clinical outcome for the patient.There were no adverse health consequences to the patient due to this event.
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Three (3) good faith attempts were made to retrieve the device; however, the aquabeam handpiece was not returned for investigation.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece/lot number 23c04637 was performed, which confirmed that there were three (3) non-conformances issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the log were segregated and reworked to address the non-conformances.The handpiece passed final inspection prior to release for distribution.The current user manual um0101-00 rev.F was reviewed and states the following: table 5: system detected errors and faults: e22: motorpack error: release foot pedal and click x.If error persists, reconnect handpiece to motorpack.If error continues, replace handpiece.The root cause of the reported event was unable to be established as the handpiece 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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