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	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept became aware that a day post-aquablation therapy, the patient expressed abdominal pain to the treating surgeon.A ct scan was performed which confirmed that the observed fluid was related to an infection.The treating surgeon stated that the patient had a rectal perforation and required a colostomy diversion.No resistance during the insertion of the trus probe was reported.The patient required extended hospitalization.No malfunction of the apogee 2300 digital color doppler ultrasound imaging system and associated component ecbp-1 trus probe were reported during this event.
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.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 treatment log files, 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: 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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: 150 baytech dr; san jose, CA 95134
• MDR Report Key: 22054911
• Report Number: 3012977056-2025-00147
• Device Sequence Number: 20622304
• Product Code: IYN
• UDI-Device Identifier: 06938396423001
• UDI-Public: 0106938396423001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2025
• Report Date (Section F): 05/13/2025

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: 04/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2025
• 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; Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 05/13/2025