A male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware of a patient sustaining a rectal perforation during an aquablation procedure with the apogee 2300 digital color doppler ultrasound imaging system and its associated ecbp-1 trus probe.Upon removal of the ecbp-1 trus probe post-aquablation procedure blood was noticed on the probe's tip.The treating surgeon performed a digital rectal evaluation, which confirmed bleeding from the rectum.A general surgeon was called in to further investigate by performing a proctoscopy, which confirmed a rectal perforation in the region near the semical vesicle and bladder.The rectal perforation is believed to have occurred during resistance encountered while inserting and repositioning the ecbp-1 trus probe into the rectum.Surgical intervention was performed to repair the perforation, along with a temporary colostomy.The patient was kept overnight, and continuous bladder irrigation was discontinued (b)(6) 2023; however, it was restarted later that afternoon due to clotting.The treating surgeon planned to keep the patient hospitalized overnight or potentially longer until the patient could tolerate food and a follow-up for reversal within 6-8 weeks.No malfunction of the apogee 2300 digital color doppler ultrasound imaging system and associated component ecbp-1 trus probe were reported during this event.
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A review of the device history record (dhr) for apogee 2300 digital color doppler ultrasound imaging system (sn: (b)(6)) and its component ecbp-1 endocavity biplane ultrasound probe related to the reported event was performed, which confirmed that there were no nonconformance, 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.The review of the operation manual for the apogee 2300 device (ifu) found that it has covered the related safety instruction: 1.6 safety l) when performing the rectal ultrasound exam, be gentle in the movement.Do not perform violent operation, otherwise it may cause risks of perforation of the rectal wall, damage to the anus and perianal tissues, damage to the rectal mucosa or bleeding.In summary, the root cause for the reported event could not be determined.The user manual of the apogee 2300 device lists rectal perforation as a potential risk of the procedure.Based on the review of dhr and ifu, the event is considered not to be device related.The information received determined that the rectal perforation was not related to the siui apogee 2300 device.Submission of this report does not constitute an admission that the manufacturer's products caused or contributed to the reported event.
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