MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; SPRAY CATHETER

Model Number	2000177
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation and evaluation of the catheter is in process; a follow-up report will be submitted when additional information becomes available.The instructions for use (ifu 150013312) contains the following instructions when using the rapid av spray kittrufreeze, "do not use the product if the device does not function properly or there is evidence of damage (e.G.Kinks, bends or damaged packaging).Save the device and packaging and contact your local steris endoscopy product specialist.".
Event or Problem Description
The user facility reported that their truefreeze console was unable to scan the catheter pouch successfully.The customer completed procedure with another catheter, subsequently causing the patient procedure to be delayed.No injuries were reported.
Additional Manufacturer Narrative
The device subject of the event was returned to steris endoscopy for evaluation.When attempting to scan the barcode on a production equivalent unit, the reported issue was confirmed.A specific root cause as to why this barcode was not readable by the trufreeze console could not be determined.The lot subject of the reported complaint had a lot size of (b)(4) units, of which two labels were reported to have had this issue.No other lots in the history of this product have been reported to have an unreadable label.Steris will continue to monitor for similar events.The user facility proceeded to file medwatch report: (b)(4), received by steris on september 18, 2024.

• Brand Name: TRUFREEZE
• Common Device Name: SPRAY CATHETER
• Manufacturer (Section D): US ENDOSCOPY; 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: 19516180
• Report Number: 1528319-2024-00046
• Device Sequence Number: 6334020
• Product Code: GEH
• UDI-Device Identifier: 00724995199227
• UDI-Public: (01)00724995199227(17)20250501(10)3510
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K223369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 05/01/2025
• Device Model Number: 2000177
• Device Catalogue Number: 2000177
• Device Lot Number: (10)3510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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