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 10/20/2021

Event Type  Injury  

Event Description

On (b)(6) 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 presented with several large hemorrhoids prior to the aquablation procedure.Post aquablation procedure, upon removal of the ecbp-1 trus probe, a component of the apogee 2300 digital color doppler ultrasound imaging system, blood was observed on the probe.The patient went into the pacu and kept overnight for observation.On (b)(6) 2021, procept was notified that the patient had rectal perforation and was placed with a temporary colostomy bag to be kept for two (2) months (per importer's instructions for use, rectal perforation is a perioperative risk of the aquablation procedure).No product malfunction was reported.

Manufacturer Narrative

Additional manufacturer narrative: root cause of reported event has not yet been established.Investigation is currently in process.

Event Description

On (b)(6) 2021, (b)(4), 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 presented with several large hemorrhoids prior to the aquablation procedure.Post aquablation procedure, upon removal of the ecbp-1 trus probe, a component of the apogee 2300 digital color doppler ultrasound imaging system, blood was observed on the probe.The patient went into the pacu and kept overnight for observation.On (b)(6) 2021, (b)(4) was notified that the patient had rectal perforation and was placed with a temporary colostomy bag to be kept for two (2) months (per importer's instructions for use, rectal perforation is a perioperative risk of the aquablation procedure).No product malfunction was reported.

Manufacturer Narrative

Additional manufacturer narrative: root cause of reported event has not yet been established.Investigation is currently in process.

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, whichconfirmed four (4) 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: 12849135
• MDR Text Key: 285987842
• Report Number: 3012977056-2021-00095
• 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: 08/15/2022

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
• 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: 08/15/2022
• Distributor Facility Aware Date: 07/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male