MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	M0052123
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: RESOLUTION 360 CLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; mentor OH 44060
• MDR Report Key: 15362815
• Report Number: MW5111874
• Device Sequence Number: 20413906
• Product Code: PKL
• UDI-Device Identifier: 00724995180881
• UDI-Public: (01)00724995180881
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2025
• Device Model Number: M0052123
• Device Catalogue Number: 00711811
• Device Lot Number: 29338569
• Was Device Available for Evaluation?: 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