MAUDE Adverse Event Report: US ENDOSCOPY ASSURANCE; ASSURANCE CLIP

Model Number	00711884
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, metal pieces from the assurance clip following deployment were found within the patient.The facility utilized a suction device to remove the pieces, and the procedure was completed successfully.No report of injury.
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.The dhr for the lot subject of the event was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A 2-year complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: ASSURANCE
• Common Device Name: ASSURANCE CLIP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4405197842
• MDR Report Key: 22751169
• Report Number: 1528319-2025-00083
• Device Sequence Number: 15603098
• Product Code: PKL
• UDI-Device Identifier: 00724995215804
• UDI-Public: (01)00724995215804(11)240103(17)270102(10)076149
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/08/2025

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: 00711884
• Device Catalogue Number: 00711884
• Device Lot Number: (10)076149
• 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: 07/09/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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