MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Resolution 360 Clip; Hemostatic Metal Clip For The Gi Tract

Model Number	M00521231
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used during a colonoscopy procedure on (b)(6)2026 for treatment of a lower gastrointestinal bleed.During the procedure, the resolution 360 clip was opened and closed.The staff then determined that the clip was not required due to the presence of excessive debris in the colon.During retrieval of the clip from the scope, the clip was no longer attached and was later found within the scope during the cleaning process.The scope was sent for repair.There were no reported patient complications.The procedure was completed, without the use of the resolution 360 clip, as the clip was determined not to be required.
Additional Manufacturer Narrative
Block h6: imrdf code a150208 captures the reportable event of device deployed in scope.

• Brand Name: Resolution 360 Clip
• Common Device Name: Hemostatic Metal Clip For The Gi Tract
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50946691
• Report Number: 3005099803-2026-03972
• Device Sequence Number: 9624402
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: M00521231
• Device Catalogue Number: M00521231
• Device Lot Number: 0039641002
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 06/22/2026
• 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