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

Catalog Number	APOGEE 2300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procept biorobotics is an importer of the apogee 2300 digital color doppler ultrasound imaging system.The system is a purchased device hence manufacture date is not available.The receiving inspection record for the apogee 2300 digital color doppler ultrasound imaging system serial number (b)(6) was reviewed.It passed the receiving inspection.No reworks were performed by procept biorobotics that were related to the reported event.The review indicated that the device met 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: 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 the apogee 2300 digital color doppler ultrasound imaging system is a reusable device; therefore, it is still currently in possession of the user facility.In summary, the root cause for the reported event is attributed to two factors: (1) patient anatomy - specifically, inherently weak and thin prostatic tissue in the mid-prostate region.(2) user error, including difficulty angling the trus probe while attempting to reach the target area.The user acknowledged an error in probe angulation.The surgeon does not attribute the rectal perforation to the aquablation therapy or device itself.The user manual of the apogee 2300 device lists rectal perforation as a potential risk of the procedure.It was reported that the aquablation procedure completed successfully without any errors or malfunction.The patient was found to have a rectal perforation.No additional surgeries or interventions were required following the aquablation procedure.The decision was made to manage the perforation conservatively, with prolonged catheterisation and an extended inpatient stay for monitoring on the ward.Patient is reported to be doing well.Based on the review of treatment log files, 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.
Event or Problem Description
On (b)(6) 2026, a male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept became aware that, post-aquablation therapy, the patient experienced rectal perforation.During focal bladder neck cautery (fbnc), the treating surgeon advanced the resection beyond the intended treatment area into the mid-prostate.The positioning and angulation of the trus probe may have contributed to this event.A small rectal tear was identified during the procedure, and the trus probe was visualized on cystoscopy.The surgeon noted that the patient's anatomy was inherently weak and had thin prostatic tissue in the mid-prostate region, which may have increased the risk of this occurrence.No additional surgeries or interventions were required following the aquablation procedure.The decision was made to manage the perforation conservatively, with prolonged catheterization and an extended inpatient stay for monitoring on the ward.The patient is reported to be doing well.The surgeon does not attribute the rectal perforation to the aquablation therapy or device itself.No device malfunction was reported during this event.

• Brand Name: APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
• Common Device Name: ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• Manufacturer (Section D): SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENT CO. LT; 77 jinsha road; shantou, guangdong 51504 1; CN 515041
• MDR Report Key: 24852492
• Report Number: 3012977056-2026-00073
• Device Sequence Number: 21039166
• Product Code: IYN
• UDI-Device Identifier: 06938396423001
• UDI-Public: 0106938396423001
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026
• Report Date (Section F): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 04/07/2026