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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On (b)(6) 2022, procept biorobotics corporation (procept), the us importer of the apogee 2300 digital color doppler ultrasound imaging system and associated component ecbp-1 trus probe, became aware that post-aquablation procedure the patient had a rectal perforation.The treating physician reported that the rectal perforation occurred with the ecbp-1 trus probe.The patient was reported to be in good condition despite the reported event.No malfunction of the ecbp-1 trus probe was reported to procept.Procept has requested additional information regarding action taken to address the rectal perforation.

Manufacturer Narrative

H.10 additional manufacturer narrative: for corrected data refer to section b.5 - describe event or problem.Submission of this report does not constitute an admission that the manufacturer's products caused or contributed to the reported event.

Event Description

On (b)(6) 2022, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On 22-jul-2022, procept biorobotics corporation (procept), the us importer of the apogee 2300 digital color doppler ultrasound imaging system and associated component ecbp-1 trus probe, became aware that post-aquablation procedure the patient had a rectal perforation.The treating physician reported that the rectal perforation occurred with the ecbp-1 trus probe.The patient was reported to be in good condition despite the reported event.No malfunction of the ecbp-1 trus probe was reported to procept.Procept has requested additional information regarding action taken to address the rectal perforation.Additional information obtained by procept through the treating surgeon confirmed that the patient was placed with a temporary colostomy bag to allow for healing of the rectal perforaiton.

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, 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 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: 15263473
• MDR Text Key: 298282458
• Report Number: 3012977056-2022-00106
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Distributor Facility Aware Date: 11/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male