A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that the aquabeam handpiece was unable to prime, triggering an "e05 - console error" on the aquabeam robotic system, which was unable to be cleared despite multiple troubleshooting steps taken in efforts to resolve the issue.As a result, the handpiece was replaced with a new unit, and the procedure was continued through successful completion.The reported event caused a surgical procedure 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 of the reported event.Visual inspection observed the handpiece pump cartridge to be corroded and the piston was unable to oscillate within the pump body.Functional testing was able to confirm the reported failure mode.A root cause for the reported event could not be determined.A review of the device history record (dhr) ab2000-b/ serial number (b)(6) and the aquabeam handpiece / lot number 23c00219 was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.Table 5: system detected errors and faults e05 - console error release foot pedal and replace handpiece.Then turn off and turn on console.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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