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

Model Number APOGEE 2300

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation is currently in process.

Event Description

On 24-sep-2021, procept biorobotics corporation (procept), the us importer of the apogee 2300 digital color doppler ultrasound imaging system, became aware that a patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Post-aquablation procedure, the treating physician noticed a small amount of blood on the ecbp-1 trus probe, a component of the apogee 2300 digital color doppler ultrasound imaging system.A retroflex view examination revealed a perforation at about 12-cm into the rectum with access into the abdominal region under the bladder (per importer's instructions for use, rectal perforation is a perioperative risk of the aquablation procedure).The patient underwent a robotic surgical closure of the rectal perforation.No visual evidence on the ultrasound image that signaled resistance was reported by the treating physician.Additional information has been requested by procept on this event.No product malfunction was reported as a result of the reported event.

Manufacturer Narrative

H.10 additional 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.No similar complaint to the reported event was found after reviewing the post-marketing surveillance data of the device.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.A similar complaint review was conducted by procept, the importer, for a 12-month period, whcih confirmed five (5) similar events have been reported during the searched period.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, 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 products caused or contributed to the reported event.

Event Description

N/a.

• 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: 12669376
• MDR Text Key: 277620601
• Report Number: 3012977056-2021-00084
• 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
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APOGEE 2300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2022
• Distributor Facility Aware Date: 06/28/2022
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male