MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; TRUFREEZE CONSOLE

Model Number	CC3-01
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with user facility personnel, it was discovered that the pump initially powered on but stopped functioning within seconds.A steris service technician provided instructions to the user facility personnel to restart the console.The user facility confirmed this resolved the issue and the unit was operating properly.The device history record was reviewed and confirmed the device subject of the event was manufactured to specifications.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the suction pump to their trufreeze console stopped working resulting in a short delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Contrary to the initial report, the device history record was not reviewed as dhrs are not applicable to the trufreeze console.

• Brand Name: TRUFREEZE
• Common Device Name: TRUFREEZE CONSOLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24215404
• Report Number: 1528319-2026-00005
• Device Sequence Number: 15503120
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006(11)231106
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/29/2026

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: CC3-01
• Device Catalogue Number: CC3-01
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown