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 3012977056-2020-00030).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 handpiece was returned for investigation.Upon visual inspection, the connector board was observed to be in unlocked position.There were no signs of fluid ingress on the connector board.Functional testing was able to reproduce the "e22 - motorpack error" with the connector board tab unlocked.The tab was locked and the "e22 - motorpack error" was not able to be reproduced during a total of 6 docking cycles, 6 simulator jet alignments on both sides, and 2 simulator 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 (1) 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.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece." "e23 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece." the root cause of the reported "e22 - motorpack error" message was determined to be failure of the connector board tab not being locked.This is the second occurrence of this nature (complaint rate of (b)(4) from 28nov2019 to 07jan2021); therefore, no escalation is required or recommended at this time.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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