A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the set-up process, while performing jet alignment, system error message "e22 - motorpack error" was displayed multiple times and troubleshot, which caused a procedural delay greater than 20-minutes.The aquabeam handpiece and aquabeam motorpack were replaced and the procedure was successfully continued to completion (refer to associated mfr.Report number 3012977056-2020-00031).There were no adverse health consequences as a result of the reported event.
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H3.Device evaluation by manufacturer: the aquabeam robotic system motorpack was returned for investigation.Functional testing was unable to reproduce the reported "e22 - motorpack error" message during a total of three docking cycles, three simulated jet alignments, and three simulated treatments.A review of the system's log file was conducted, which confirmed the reported "e22 - motorpack error" message in addition to "e23 - motorpack error" message.The total delay was determined to be 22 minutes.The procedure was observed to have proceeded to completion.A review of the device history record (dhr) for serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar events confirmed one other event has been reported for this issue.The aquabeam robotic system's user manual (intl), um0101-00, rev.E, states the following in 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." "e23 - motorpack error release foot pedal and click x.If error persists, reconnect handpiece to motorpack.If error continues, replace handpiece.".No problem was found with the returned aquabeam robotic system motorpack.Functional testing was unable to reproduce the reported "e22 - motorpack error" message during a total of three (3) docking cycles, three simulated jet alignments, and three simulated treatments.The reported event was determined to be related to the associated aquabeam robotic system handpiece (refer to associated mfr.Report number 3012977056-2020-00031).Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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