A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during procedural setup, the aquabeam robotic system generated an "e22 - motorpack error" message.Multiple troubleshooting steps attempted to clear the error message were unsuccessful.A second aquabeam handpiece was used and the aquablation procedure began.During nozzle registration, the high-velocity waterjet was not firing and the aquabeam robotic system generated an "lp jet" message.Multiple troubleshooting steps were attempted; however, the high-velocity waterjet still wouldn't fire.A third aquabeam handpiece and second aquabeam motorpack were used to resolve the issue.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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Three (3) good faith attempts were made to retrieve the device; however, the aquabeam handpiece was not returned for investigation.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c00339 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 review indicated that the device met all design and manufacturing specifications when released for distribution.The current instructions for use ifu0101-00 rev.E , states the following: 8.30 sterile: treatment: a.To begin the aquablation treatment, step on the foot pedal and gently support the beige braided tubing extending from the back of the aquabeam handpiece.Caution (for system models other than ab2000c): failure to support the beige braided tubing may result in a system fault or insufficient cutting efficacy.A.During the aquablation treatment, use [-] indicator on the motorpack to decrease power/resection depth (if needed) and use [+] to increase back to planned power.The root cause of the reported event was unable to be established as the handpiece 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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