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 12/05/2023

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 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.Resistance was also met while trying to advance the ecbp-1 trus probe within the rectal channel.Approximately 45 minutes into resection, the treating surgeon indicated that he could see the ecbp-1 trus probe at 5 o'clock, lateral to the veru on the left side.This is indicative of a prostate capsule perforation.Upon removal of the ecbp-1 trus probe post-aquablation procedure blood was noticed on the entirety of the ecbp-1 trus probe.Further investigation by ultrasound support was unable to produce additional information.The treating surgeon performed a digital rectal evaluation and requested colorectal support.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 into the rectum.The patient was scoped four days post-operation and was "healing well".The patient is reported to be doing "very 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

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.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 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.Submission of this report does not constitute an admission that the manufacturer's products caused or contributed to the reported event.

Manufacturer Narrative

H11: update to investigation conclusion provided in follow-up 1 report.The investigation conclusion should state: in summary, the root cause for the reported event could not be determined.It was reported that the treating surgeon perforated both the prostate capsule and rectal wall with the bipolar loop during hemostasis.The user manual of the apogee 2300 device lists rectal perforation as a potential risk of the procedure.The aquabeam robotic system instructions for use (ifu) list prostate capsule perforation as a potential risk of the aquablation 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 and prostate capsule perforation were not related to the siui apogee 2300 device.Submission of this report does not constitute an admission that the manufacturer's products caused or contributed to the reported 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: 18419573
• MDR Text Key: 331618788
• Report Number: 3012977056-2023-00260
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 06938396423001
• UDI-Public: 0106938396423001
• 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,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: 04/08/2024
• Distributor Facility Aware Date: 03/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male