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	Laceration(s) (1946)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procept biorobotics is an importer of the ecbp-1, siui trus probe.The device history record could not be performed as the serial number of the ecbp-1, siui trus probe is unknown.The treatment log files were reviewed, which confirmed no malfunction occurred and the system functioned as intended.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.The root cause of the reported event is attributed to user error.It was reported that a small laceration on the outside of the patient's rectum was inadvertently made by the resident during trus insertion.The resident had difficulty locating the patient's rectum, and the treating surgeon had to step in.The treating surgeon was made aware of the presence of blood, and a small laceration was observed on the outside of the patient's rectum.The laceration was closed with stitches after completion of aquablation therapy, and the patient has since been discharged.The apogee 2300 user manual lists damage to the rectal mucosa as a potential risk of the procedure.Based on a review of the information provided and the dhr and ifu, the event is considered not device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
Event or Problem Description
A male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics (procept) became aware that, during aquablation therapy, a small laceration on the outside of the patient's rectum was inadvertently made by the resident during trus insertion.The resident had difficulty locating the patient's rectum, and the treating surgeon had to step in.The treating surgeon was made aware of the presence of blood, and a small laceration was observed on the outside of the patient's rectum.The laceration was closed with stitches after completion of aquablation therapy, and the patient has since been discharged.No malfunction of the aquabeam robotic system was reported.

• 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: 25247694
• Report Number: 3012977056-2026-00098
• Device Sequence Number: 13369230
• Product Code: IYN
• UDI-Device Identifier: 06938396423001
• UDI-Public: 0106938396423001
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 05/21/2026
• Report Date (Section F): 05/20/2026

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
• Distributor Facility Aware Date: 04/29/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• 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: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 05/20/2026