MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRUFREEZE CONSOLE SYSTEM

Model Number CC301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The steris product specialist requested the trufreeze log files for review.The log files were reviewed and no issues were noted with the function or operation of the device.Steris offered in-service training on the proper use and operation for the trufreeze console system however, the user facility declined.The trufreeze console system remains in use at the user facility and no additional issues have been reported.

Event Description

The user facility reported that a stomach perforation occurred during use of the trufreeze console system for treatment of squamous esophageal dysplasia.The perforation was closed, and the procedure was completed.The patient was discharged home and is reported to be fine.

• Brand Name: TRUFREEZE CONSOLE SYSTEM
• Type of Device: CONSOLE SYSTEM
• 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: 18961621
• MDR Text Key: 338768963
• Report Number: 1528319-2024-00023
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC301
• Device Catalogue Number: CC301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1