MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; TRUFREEZE CONSOLE

Model Number	CC301
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a trade show event, a trufreeze console was used on two individuals to attempt to treat the skin; irritation was reported as a result.
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The investigation determined that the trufreeze console was used outside of a clinical setting by an individual who was not a licensed medical professional.Use under these conditions is inconsistent with the device's intended use and labeling.Steris implemented corrective actions to prevent recurrence, including mandatory training for steris's procedural endoscopy and clinical teams who serve as the company stewards of the trufreeze product, to reinforce appropriate use, handling, and oversight of the device.No further complaints or reports of skin irritation related to this event have been received since the initial report.

• Brand Name: TRUFREEZE
• Common Device Name: TRUFREEZE CONSOLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4403586251
• MDR Report Key: 23572958
• Report Number: 1528319-2025-00105
• Device Sequence Number: 10205758
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006(11)220928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K223369
• 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): 11/17/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• 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