MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; TRUFREEZE CONSOLE

Model Number	CC3-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their trufreeze console generated a suction error during their daily startup process.Patient procedures were postponed for the day.No report of injury.
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.No additional issues have been reported.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the suction pump of the console was not operating properly, however a cause of the reported event could not be determined.To resolve the issue, the technician replaced the suction pump.The unit was tested, confirmed to be operating according to specification, and returned to service.The log files for the trufreeze system were reviewed and no abnormalities were noted.No additional issues have been reported.
Additional Manufacturer Narrative
Contrary to the previous report, the log files were not obtained for review.No additional issues have been reported.

• 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: 22482366
• Report Number: 1528319-2025-00075
• Device Sequence Number: 18267302
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006(11)240627
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/11/2025

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: 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: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 03/26/2026; 03/30/2026; 04/20/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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