MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; CRYODECOMPRESSION TUBE

Model Number	2000181
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Crepitus (4893)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure two wires of their cryo decompression tube were exposed and resistance was felt by user facility personnel while operating the tube.User facility personnel attempted to straighten out the wiring of the tubing but were unsuccessful.The procedure was completed successfully following a short delay using another device.Upon completion of the procedure, crepitus was noticed on the back of the patient's neck.Medical treatment was administered to remove the crepitus; however, it is unknown what type of medical treatment was administered.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, an exact cause of the reported event cannot be determined.The cryo decompression tube instructions for use states, "inspect the pouch contents for damage prior to use.Do not use the active venting cdt if any part of the product is damaged in any way.Do not use the product if the device does not function properly or there is evidence of damage (e.G.Kinks, bends or damaged packaging).Save the device and packaging and contact your local steris endoscopy product specialist.Expired product should not be used." steris offered in-service training on the proper use and operation of the cryo decompression tube; however, the user facility declined.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: TRUFREEZE
• Common Device Name: CRYODECOMPRESSION TUBE
• 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 ; 4404130648
• MDR Report Key: 21857508
• Report Number: 1528319-2025-00033
• Device Sequence Number: 20013497
• Product Code: GEH
• UDI-Device Identifier: 00724995199210
• UDI-Public: (01)00724995199210
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/17/2025

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: 2000181
• Device Catalogue Number: 2000181
• 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: 03/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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