A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the first treatment pass, while the handpiece was inside the patient, the aquabeam handpiece stopped pumping water from the aquabeam console.A second handpiece was used and the aquablation procedure was successfully completed.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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The aquabeam handpiece was returned for investigation.Visual inspection of the returned device observed to have no physical damages or anomalies.The reported event could not be confirmed as no issues were observed before, during, or after the treatment phase and a simulated aquablation session was performed successfully.Additionally, the handpiece probe tip was observed under magnification.No physical damage, obstruction, or blockage could be seen that would affect jetting.The root cause is no problem found as the handpiece was found to be functioning as intended.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c01756 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 instruction for use ifu0101-00 rev.E, aquabeam robotic system ifu, us, english was reviewed.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.Submission of this report does not constitue an admission that the manufacturer's product caused or contributed to the event.
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