A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure a rectal perforation occurred.The patient underwent a digital rectal exam (dre) and coloscopy procedure, which confirmed a perforation on the posterior wall of the rectum.The bk transrectal ultrasound (trus) probe most likely caused the perforation (per manufacturer's instructions for use, rectal perforation is a potential perioperative risk of the aquablation procedure).The bk transrectal ultrasound (trus) probe is a non-procept biorobotics' device.The patient got a temporary anus praeter to protect the anastomosis, which was removed in a second surgery.The treating physician reported no issues related to the aquablation procedure with the patient.
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H3.Device evaluation by manufacturer: the aquabeam robotic system was not returned for investigation as it is currently in use at the user facility.A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for ab2000-b rev b/serial number (b)(6) was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.A review for similar complaints across all systems confirmed six (6) similar events.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.B, 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 rectal perforation.A root cause for the reported event could not be determined.The aquabeam robotic system's ifus lists rectal perforation as potential risk of the aquablation procedure.Based on the review of the log file, dhr and ifu, the event is considered not to be device related.The information received determined that the rectal perforation was caused by the bk transrectal ultrasound (trus) probe, which is a non-procept biorobotics device.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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