A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure, which could be related to the reported event.The system functioned as designed.A review of the device history record (dhr) serial number (b)(4) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar events was conducted on the aquabeam system, serial number (b)(4), which confirmed that there were no other similar events reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu320301, rev.C, states the following: warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: - rectal perforation.The system was not returned for investigation of this event.Per the ifu, rectal perforation is a potential risk of the aquablation procedure.Based on the review of the information received, log file, dhr, and ifu, the event is considered not to be device related.
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A male patient underwent an aquablation procedure.During the aquablation procedure, a rectal perforation occurred with a transrectal ultrasound (trus) probe (per manufacturer's instructions for use, rectal perforation is a potential perioperative risk of the aquablation procedure).The transrectal ultrasound (trus) probe is a non-procept biorobotics' device.No additional information was provided on this event.No malfunction of the aquabeam system was reported.
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An article published in the world journal of urology reported the results of a multi-center study examining physicians' lessons learned with the aquablation surgical procedure for the treatment of benign prostatic hyperplasia (bph).The article published on 26-mar-2021 reported two (2) patients with rectal perforation, which occurred during aquablation surgical procedures.In the first case, the diagnosis was made two (2) days after the aquablation procedure due to unspecific postoperative symptoms.A complex combined open/endoscopic repair of the defect was carried out thereafter.This mdr was reported under this report.In the second case, intraoperative rectoscopic after uneventful aquablation revealed the rectal perforation.The perforation was clipped immediately with an over the scope-clip by colonoscopy.This event was reported to the agency under mfr.Report # 3012977056-2021-00025.
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