MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	2000184
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When using cryo catheter, you must scan the rapid av venting catheter package before liquid nitrogen will be released.Package would not scan.

• Brand Name: TRUFREEZE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 20245651
• Report Number: 20245651
• Device Sequence Number: 7397844
• Product Code: GEH
• UDI-Device Identifier: 00724995199333
• UDI-Public: (01)00724995199333
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2000184
• Device Catalogue Number: 2000184
• Device Lot Number: 3510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 06/05/2024