A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedural setup, the aquabeam robotic system generated an "e22 - motorpack error".Despite multiple troubleshooting attempts, the issue persisted.As a result, the aquablation procedure was aborted and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.
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The aquabeam handpiece was returned for investigation.Functional testing was unable to replicate the e22 error.A review of the treatment log files found no occurrences of e22 errors.The root cause of the reported error is undeterminable.A review of the device history record (dhr) ab2000-b / serial number 19c01179 and aquabeam handpiece / lot number 23c02238 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 failure.The review indicated that the device 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 and states: 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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