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

Model Number CC301

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

The user facility reported that their trufreeze system did not pass the scan sequence before the device's operation, subsequently causing the patient procedure to be postponed.No injuries were reported.

Manufacturer Narrative

A steris service specialist arrived onsite and found that user facility personnel did not properly fill the console and did not wait for the console to reach optimal scanning pressure as instructed in the operator manual.No issues were noted with the function or operation of the trufreeze system and was found to be operating according to specification.While onsite the service specialist installed a fresh copy of the load package and replaced a transfer seal due to normal wear and tear of the device over time.The trufreeze system was returned to service.The steris service specialist further discussed the reported event and investigation findings with user facility personnel and counseled them on the proper use and operation of the device.In the troubleshooting section of the operator manual (pp.56), if the scan is not activating "cancel scan if applicable.Check ln2 level and allow pressure to build.Fill tank if necessary.Scan is not allowed with low ln2 level or pressure to prevent using a catheter if there is insufficient ln2 to perform a procedure." no additional issues have been reported.

• Brand Name: TRUFREEZE SPRAY CRYOTHERAPY SYSTEM
• Type of Device: CRYOTHERAPY 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: 14654709
• MDR Text Key: 301981340
• Report Number: 1528319-2022-00033
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: 00857068006006
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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