A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during jet alignment, no movement of the high-velocity waterjet was seen on the aquabeam handpiece despite multiple troubleshooting steps.As a result, the aquabeam handpiece was replaced with a new handpiece unit, and the procedure was successfully completed.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 of the returned handpiece did not reveal any anomalies.Functional testing of the returned handpiece confirmed the reported event.Additional analysis of the inlet valve identified severe warping on the cap area.A review of the device history record (dhr) ab2000-b/ serial number (b)(6), and aquabeam handpiece with lot number 23c01311 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 aquabeam robotic system ifu, ifu0101-00 rev.F, states the following: 8.14 sterile: ensure the aquabeam scope is fully advanced prior to priming.Press the "prime" button on the foot pedal or console and circle priming indicators (100% and 50%) will appear on the cpu.Press the [+] button on either the console or the motorpack to prime the aquabeam handpiece at 100% power level.Continue to press the [+] button until the 100% yellow indicator turns green.Release the [+] button while pressing the prime button until the 50% yellow indicator turns green.The root cause is likely the supplier, as the inlet valve are supplied through an external supplier.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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