A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation procedure and before hemostasis protocol, the treating surgeon noticed bladder neck undermining.It was reported that the prostate tissue was within the fossa and to the right of where bladder neck undermining was noticed on the ultrasound.The treating surgeon was able to achieve hemostasis.The patient was discharged following the procedure.Upon a two-week follow-up with the treating surgeon, the patient's catheter was removed, and the patient was reported to be doing well.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 treatment log files, device history record (dhr), and instructions for use (ifu).The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b/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: o bladder or prostate capsule perforation a root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists prostate capsule perforation as a potential risk of aquablation therapy.Based on the review of the event details, plus the treatment log files, 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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