MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; VENTING SPRAY

Model Number	2000516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their active venting spray catheter began to leak after it was connected to the trufreeze console and the cryo foot pedal was activated.The procedure was completed successfully following a short delay using a pulmonary catheter.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.Upon evaluation, it was discovered that the catheter near the proximal end of the device was broken, however it could not be determined if the catheter broke during a procedure or during the return shipment to steris for evaluation.A cause of the reported event could not be determined.The active venting spray ifu states, "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 when using a scope, place the catheter through the catheter introducer and into the biopsy or working channel of the scope.Ensure catheter and scope are completely defrosted before repositioning or withdrawing catheter.Withdraw catheter in the straight position.Care should be taken to avoid kinking or fracturing the catheter during handling and insertion into the catheter introducer." a steris account manager conducted in-service training with user facility personnel on the proper use and operation of the active venting spray.A 1-year complaint review confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: TRUFREEZE
• Common Device Name: VENTING SPRAY
• 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: 23946471
• Report Number: 1528319-2026-00001
• Device Sequence Number: 10758237
• Product Code: GEH
• UDI-Device Identifier: 00724995199326
• UDI-Public: (01)00724995199326(11)250901(17)270901(10)5526
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 2000516
• Device Catalogue Number: 2000516
• Device Lot Number: (10)5526
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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