A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware during the aquablation procedure, multiple "e208 - motorpack error" messages were generated by the aquabeam robotic system.Multiple troubleshooting steps were performed to resolve the issue without success.However, once the power reached 80%, the occurrence of error codes ceased and the procedure was continued through successful completion.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 as it was disposed of at the user facility.The aquabeam robotic system's treatment logs file was reviewed, which confirmed the reported event.A review of the device history record (dhr) (b)(4) / serial number (b)(6) and aquabeam handpiece / lot number 22c00254 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 um0201 aquabeam robotic system user manual, p1g3, english was reviewed.Section 19.Aquabeam robotic system detected errors, faults, and messages table 6.System display message (recommended action) e208 - motorpack error release foot pedal and click x.1) if error persists, reconnect motorpack, 2) if error continues, replace motorpack.The root cause of the reported event could not be established as the handpiece was not returned for investigation.Submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.
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