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" message.A second aquabeam handpiece was used, but the error persisted.As a result, the aquablation procedure was aborted and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.
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H.6 adverse event problem component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.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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The aquabeam motorpack was not returned for investigation of the reported event.Three (3) good faith efforts were made to retrieve the device without success.The current user manual um0104-00 rev.G, aquabeam robotic system user manual, intl (ce), 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.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(4) and the aquabeam motorpack / lot number 22c04369 was performed, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported failure.The motorpack passed final inspection prior to release for distribution.A review of the treatment log files was able to confirm the reported event of the "e22 - motorpack error"'; however, the root cause of the reported event was unable to be established as the device was not returned for investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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