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.A second aquabeam motorpack was used, but the error persisted.A second aquabeam handpiece was used; however, the aquabeam robotic system generated an "e50 - console error".As a result, the aquablation procedure was aborted.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 um0104-00 rev.G, aquabeam robotic system user manual, english, states the following: 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 (b)(6) was performed, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformance.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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