MAUDE Adverse Event Report: US ENDOSCOPY SCLEROTHERAPY NEEDLE

Model Number	MD-A-SY-2423-2104
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, their fastflo sclerotherapy needle was "dull, tearing the tissue".There was no additional medical intervention required.The procedure was completed successfully using a different needle.
Additional Manufacturer Narrative
Investigation of the reported event is in process.A follow-up report will be submitted once additional information becomes available.

• Brand Name: SCLEROTHERAPY NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24634062
• Report Number: 1528319-2026-00022
• Device Sequence Number: 8688492
• Product Code: GEH
• UDI-Device Identifier: 06970401815722
• UDI-Public: (01)06970401815722(17)251026(10)20221027
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/18/2026

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: 10/26/2025
• Device Model Number: MD-A-SY-2423-2104
• Device Lot Number: (10)20221027
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• 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