MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; TRUFREEZE CONSOLE SYSTEM

Model Number	CC3-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the time of the reported event, user facility personnel contacted steris service as instructed in the trufreeze console system operator manual.The operator manual in the troubleshooting section gives the following instructions to the user: "if console is not behaving as expected, power cycle the console.If problem persists, contact steris customer service at 1-800-769-8226 or your local steris endoscopy product specialist.Warning: do not use the system if the system has indicated an alarm; user or patient injury or device damage may result.Investigate the alarm and contact steris endoscopy if the cause cannot be determined or corrected.Caution: depressing the emergency stop button on the front of the console halts the cryogenic delivery system and releases the pressure in the cryogen tank.Caution: a low pressure (30 psi max, 22 psi recommended), medical grade liquid nitrogen source must be used to fill the console.Filling from a high-pressure source tank may result in equipment damage or operator injury." user facility personnel restarted the trufreeze console system, tested the function and operation of the device and completed the patient procedure.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 system was not operating properly.The procedure was completed successfully following a short delay.No report of injury.

• Brand Name: TRUFREEZE
• Common Device Name: TRUFREEZE CONSOLE SYSTEM
• 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: 24713033
• Report Number: 1528319-2026-00025
• Device Sequence Number: 5677087
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006(11)220628
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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: 02/25/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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