MAUDE Adverse Event Report: SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT SIUI; APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

Model Number APOGEE 2300

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 06-jul-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).The patient was administered spinal anesthesia.During the insertion of the ecbp-1 trus probe, a component of the apogee 2300 digital color doppler ultrasound imaging system, the patient moved, and it seems the continuing insertion of the trus probe caught a transverse fold of the rectal wall causing a rectal perforation (per procept's instructions for use, rectal perforation is listed as a potential perioperative risk of the aquablation procedure).A general surgeon assisted in suturing the submucosal wall of the rectum right after the procedure as part of the same operative sitting.No product malfunction was reported as a result of the reported 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 endocavitary biplane ultrasound probe (sn: (b)(6) 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.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.

• Brand Name: SIUI
• Type of Device: APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT; 77 jinsha road; shantou, guangdong, 51504 1; CH 515041
• MDR Report Key: 12299379
• MDR Text Key: 265780870
• Report Number: 9615439-2021-00001
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 06938396423001
• UDI-Public: 0106938396423001
• Combination Product (y/n): N
• PMA/PMN Number: K173000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention