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	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause of the reported event has not yet been established.Investigation is currently in progress.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
Event or Problem Description
On (b)(6) 2024, a male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept became aware that post aquablation therapy, the patient complained of pain.Upon inspection, the patient¿s abdomen was noted to be distended and computed tomography (ct) imaging with contract was performed, revealing a rectal perforation.On (b)(6) 2024, an exploratory laparotomy and subsequent bowel diversion procedure were performed.The patient remains hospitalized under observation and a discharge plan has not yet been determined.It was reported that no issues were experienced during the aquablation therapy, and the patient did not have anything unusual with his anatomy.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
On (b)(6) 2024, procept received additional information which indicated that the patient remains hospitalized, but he may soon be discharged to a skilled nursing facility.
Additional Manufacturer Narrative
Additional information was received on 21-nov-2024 indicating that the patient has been transitioned from the hospital to an intermediate care facility.No details on the length of stay in the intermediate care facility or future plans were available.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.

• 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: 20578645
• Report Number: 3012977056-2024-00248
• Device Sequence Number: 12892032
• Product Code: IYN
• UDI-Device Identifier: 06938396423001
• UDI-Public: 0106938396423001
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 11/26/2024
• Report Date (Section F): 11/26/2024

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: 11/15/2024
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/19/2024; 11/26/2024
• 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: 11/26/2024