MAUDE Adverse Event Report: SCLEROTHERAPY NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Resolution clip - while tech tried to clamp down with resolution clip it would not close appropriately and pulled to the side.Sclerotherapy needle, while trying to push the needle out the hardware of the handle pulled away.Fda safety report id# (b)(4).

• Brand Name: SCLEROTHERAPY NEEDLE
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• MDR Report Key: 15362815
• Report Number: MW5111874
• Device Sequence Number: 20413907
• Product Code: PKL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown