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

Model Number CC301

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

Patient Problem Pneumothorax (2012)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

A steris endoscopy representative was present during the procedure and stated that the user facility used the appropriate spray catheter and patient monitoring.There was no evidence of any malfunction of the trufreeze system during the procedure.A steris endoscopy review of the trufreeze system console log confirmed normal operation.The disposable catheter was not returned by the user facility to steris endoscopy for evaluation.The instructions for use for the trufreeze system includes the following warnings and precautions: "the physician should carefully consider patient eligibility for cryospray ablation (i.E., cryosurgery and associated gas pressure), including patient presentation, medical history, comorbidities (e.G., copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray." a follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that a distal pneumothorax was detected following a spray cryotherapy procedure which included use of the trufreeze system.The patient recovered and was discharged the following day with no further issues reported.

Manufacturer Narrative

Additional information was requested from the user facility; however, no further information was provided to steris endoscopy.

• 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: 12068577
• MDR Text Key: 259226676
• Report Number: 1528319-2021-00022
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2021
• 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