A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that two months post-aquablation treatment, the patient presented with sepsis.The patient was given antibiotics and a catheter was placed, which resolved the reported issue within 2 days from the initial occurrence.However, the root cause of this event remains unidentified.The treating surgeon confirmed that the aquabeam robotic system functioned as intended, and assessed the event to be likely related to the procedure.No malfunction of the aquabeam robotic system was reported.
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The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and labeling.A review of the device history record (dhr) ab2000-c/serial number (b)(6) 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 instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3 warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: infection.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The device was not returned for investigation because it performed as intended during the aquablation procedure and was confirmed through our investigation of the event.The aquabeam robotic system's ifu lists infection as a potential risk of the aquablation procedure.Based on the review of the dhr, and ifu the event is considered not to be device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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