MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPID AV SPRAY CATHETER KIT

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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without a returned device, the root cause cannot be determined.The device review history (dhr) for the subject lot was reviewed, and no abnormalities were found, and no other complaints associated with the subject lot.The log files for the console were reviewed, and no abnormalities noted.A complaint review was conducted for this lot and indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the rapid av spray catheter to their trufreeze console sprayed black residue onto the patient's tissue on the initial spray.The procedure was completed with the same catheter.No report of injury.No report of procedure delay.

• Brand Name: RAPID AV SPRAY CATHETER KIT
• Common Device Name: RAPID AV SPRAY CATHETER KIT
• 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: 16638210
• Report Number: 1528319-2023-00007
• Device Sequence Number: 20444565
• Product Code: GEH
• UDI-Device Identifier: 00724995199227
• UDI-Public: 00724995199227
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 2000177
• Device Catalogue Number: 2000177
• Device Lot Number: 2504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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