Catalog Number AB2000 |
Device Problem
Visual Prompts will not Clear (2281)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Event Description
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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", "e23 - motorpack error", and "e50 - console error" messages, which could not be cleared.Despite troubleshooting with two (2) other aquabeam handpieces, the issue persisted.A fourth aquabeam handpiece was used, which successfully resolved the issue, and the aquablation procedure was completed successfully.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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Manufacturer Narrative
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Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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Manufacturer Narrative
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The aquabeam handpiece was returned for an investigation.No visual defects or anomalies were observed with the handpiece.Functional testing was able to confirm the reported e22 error, but only for the first docking cycle.Further analysis found no signs of fluid ingress were observed on the sensor board and encoder wheel.The root cause for the reported failure is undeterminable.The issue has been addressed as part of procept's quality management system.A review of the device history record (dhr) ab2000-b / serial number (b)(6)and aquabeam handpiece / lot number 23c05214 was conducted, 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 reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.The aquabeam robotic system user manual, um0101 rev.F, 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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Search Alerts/Recalls
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