MAUDE Adverse Event Report: US ENDOSCOPY ASSURANCE; ASSURANCE CLIP

Model Number	00711885
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has notified the supplier, ags medtech of the reported event.The device subject of the reported event was not returned for evaluation.Without the return of the device, an exact cause could not be determined.Steris offered in-service training on the proper use and operation of the assurance clip; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a piece of wire from their assurance clip was protruding following deployment.The wire was removed from the patient to complete the procedure successfully.No report of injury.

• Brand Name: ASSURANCE
• Common Device Name: ASSURANCE CLIP
• 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: 24523663
• Report Number: 1528319-2026-00020
• Device Sequence Number: 9704175
• Product Code: PKL
• UDI-Device Identifier: 00724995219154
• UDI-Public: (01)00724995219154(11)250601(17)280531(10)097198
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172727
• 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): 03/05/2026

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 Model Number: 00711885
• Device Catalogue Number: 00711885
• Device Lot Number: (10)097198
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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