MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; RAPID AV CATHETER

Model Number	20-00177
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process.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 multiple rapid av catheters would not scan with their trufreeze console resulting in a procedure delay.The procedure was completed using a different modality.No report of injury.

• Brand Name: TRUFREEZE
• Common Device Name: RAPID AV CATHETER
• 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: 24333807
• Report Number: 1528319-2026-00013
• Device Sequence Number: 21279702
• Product Code: GEH
• UDI-Device Identifier: 00857068006099
• UDI-Public: (01)00857068006099(17)260201(10)4506
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/13/2026

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 Expiration Date: 02/01/2026
• Device Model Number: 20-00177
• Device Catalogue Number: 20-00177
• Device Lot Number: (10)4506, (10)4515
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/13/2026
• 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