A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during treatment, the aquabeam robotic system generated an "e22 - motorpack error".Multiple troubleshooting steps were performed; however, the issue persisted.A second aquabeam handpiece was used which resolved the reported issue.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 returned for investigation.During functional testing, multiple "e22 - motorpack" errors were triggered.The error could not be cleared, as it would trigger shortly after pressing the foot pedal.The aquabeam handpiece was then tested on the microstepper and no signal anomalies were noted.The aquabeam handpiece was deconstructed and observed under magnification.No signs of fluid ingress or anomalies were observed.The root cause of the reported error was unable to be determined.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c11055 was conducted, which confirmed that there were two (2) non-conformances 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 current user manual sj-um0101-00 rev.B, um, aquabeam robotic system user manual, us, baytech was reviewed and 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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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