MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; ACTIVE VENTING CRYO DECOMPRESSION TUBE

Model Number	2000181
Medical Device Problem Code	Break (1069)
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
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the wire of their active venting cryo decompression tube "poked" the patient during a patient procedure.The procedure was completed successfully with another active venting cryo decompression tube.No report of injury or procedure delay.

• Brand Name: TRUFREEZE
• Common Device Name: ACTIVE VENTING CRYO DECOMPRESSION TUBE
• 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: 24261044
• Report Number: 1528319-2026-00007
• Device Sequence Number: 9600101
• Product Code: GEH
• UDI-Device Identifier: 00724995199210
• UDI-Public: (01)00724995199210(10)5501
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 2000181
• Device Catalogue Number: 2000181
• Device Lot Number: (10)5501
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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