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 Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procept biorobotics markets the endocavity biplane ultrasound probe (product number: ecbp-1) and the apogee 2300 digital color doppler ultrasound imaging system for use in aquablation therapy with procept biorobotics' aquabeam robotic system.The ecbp-1 ultrasound probe is manufactured by shantou institute of ultrasonic instruments co., ltd.(siui).Sections of chapter 5 - probe cleaning and disinfection in the ecbp-1 english operation manual (document no.: sscr9890000ena)has covered various cleaning and disinfection procedures that are acceptable to /compatible with the probe.However, for different countries and regions, users need to refer to local laws, regulations and directives to select suitable procedures, for the us area, as the requirement of "vi.Fda's six criteria for reprocessing instructions- b.Semi-critical devices" in the us fda guidance "reprocessing medical devices in health care settings: validation methods and labeling" :" if the device design does not permit sterilization (e.G., device materials cannot withstand sterilization), then high level disinfection should be used.".If the user does not follow the requirement, the user operation may fail to comply with fda regulation.In 5.1 overview of chapter 5 probe cleaning and disinfection of ecbp-1_english operation manual (document no.: sscr9890000ena), it is required that "the disinfection shall be high-level disinfection (by semi-immersion or full-immersion).According to customer feedback, if the end user does not strictly follow the requirements in the overview and does not handle the probe reprocessing in accordance with local regulations, it may result in the risk of cross-infection.Since the ecbp-1 ultrasound probe is used with the aquabeam robotic system,procept biorobotics and siui are providing the customers/users with product notification to provide reprocessing and disinfection information to reduce potential risks to patients.

• 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
• Manufacturer (Section G): SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT; 77 jinsha road; shantou, guangdong, 51504 1; CH 515041
• Manufacturer Contact: flower cai ; 77 jinsha road; shantou, guangdong, 51504-1 ; CH 515041
• MDR Report Key: 13375753
• MDR Text Key: 294658450
• Report Number: 9615439-2022-00001
• Device Sequence Number: 1
• Product Code: IYN
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APOGEE 2300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1