MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CRYO DECOMPRESSION TUBE

Lot Number	3519
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a trufreeze spray cryotherapy procedure, wires inside their cryo decompression tube loosened and began to pull out of the tube.The procedure was completed successfully with another device.No report of injury.
Additional Manufacturer Narrative
The device was returned to steris endoscopy for evaluation which identified that the wires inside the decompression tube were severely bent.Bent wires inside the cryo decompression tube are indicative of excess force applied by user facility personnel.In-service training was offered on proper use of the cryo decompression tube, but the user facility declined.The 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.Cutting or otherwise altering the active venting cdt may decrease the flow of nitrogen gas through the cdt, resulting in an increased risk of perforation, stricture, or other damage to the ablation area.To avoid kinking the cdt, use only short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, throughout device insertion." a complaint review determines this to be an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: CRYO DECOMPRESSION TUBE
• Common Device Name: DECOMPRESSION TUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19493596
• Report Number: 1528319-2024-00045
• Device Sequence Number: 8538519
• Product Code: GEH
• UDI-Device Identifier: 00724995199210
• UDI-Public: 00724995199210
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/07/2024

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 Lot Number: 3519
• 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: 05/08/2024
• Initial Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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