MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRUFREEZE CONSOLE

Model Number	CC301
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with the user facility, the trufreeze business manager learned that an employee was refilling their trufreeze console on the loading dock at the user facility.Contrary to the reported event, it was confirmed that all wheels were present on the console.However, it is likely that the wheel locks were not engaged resulting in the reported event.The trufreeze filling instructions step 1 states, "roll trufreeze console to fill site and lock wheels." due to the reported event the trufreeze console sustained damaged, and the user facility was provided with a loaner unit.The trufreeze clinical specialist scheduled in-service training for august 21, 2023, on how to properly fill the trufreeze console, specifically on locking the wheels before filling.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee attempted to stop their trufreeze console from rolling off the loading dock, injuring the employee's back and arm.The employee stated that one of the wheels fell off their trufreeze console.Medical treatment was sought, but the user facility did not disclose if medical treatment was administered.

• Brand Name: TRUFREEZE CONSOLE
• Common Device Name: TRUFREEZE CONSOLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 17404818
• Report Number: 1528319-2023-00031
• Device Sequence Number: 5900360
• Product Code: GEH
• UDI-Device Identifier: 00724995199296
• UDI-Public: 00724995199296
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: CC301
• Device Catalogue Number: CC301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown