MAUDE Adverse Event Report: SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO. LT SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM; ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

Catalog Number APOGEE 2300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

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 at the anterior rectum during an aquablation procedure with the apogee 2300 digital color doppler ultrasound imaging system and its associated ecbp-1 trus probe.It was reported that the treating surgeon met resistance while inserting and repositioning the ecbp-1 trus probe into the rectum.Upon removal of the ecbp-1 trus probe post-aquablation procedure, blood was noticed on the probe cover.The treating surgeon immediately performed a digital rectal evaluation and more blood was noted.The treating surgeon requested colorectal support and a colorectal surgeon sutured the rectum to repair the perforation.The rectal perforation is believed to have occurred during resistance encountered while inserting and repositioning the ecbp-1 trus probe in the rectum.The colorectal surgeon believes that the probe most likely caught a rectal valve 2-3 inches into the patient's rectum.The patient is reported to be doing well.No malfunction of the apogee 2300 digital color doppler ultrasound imaging system and associated component ecbp-1 trus probe were reported during this event.

Manufacturer Narrative

H.11 additional manufacturer narrative: the apogee 2300 digital color doppler ultrasound imaging 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 therapy and was confirmed through our investigation of the event.A review of the treatment log indicated that a touch on the conservative side of planning otherwise straight forward.Waterjet depth was no where near the rectal wall.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.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.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, post-marketing data 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 product caused or contributed to the event.

• Brand Name: SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
• Type of Device: ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• Manufacturer (Section D): SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO. LT; 77 jinsha road; shantou, guangdong 51504 1; CH 515041
• MDR Report Key: 18797140
• MDR Text Key: 336437837
• Report Number: 3012977056-2024-00041
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: APOGEE 2300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2024
• Distributor Facility Aware Date: 04/08/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male