MAUDE Adverse Event Report: US ENDOSCOPY ASSURANCE; CLIP

Model Number	00711885
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported while using their assurance clip during a patient procedure that the clip was only able to partially deploy.While attempting to fully deploy the clip, the clip's inside metal hook detached and fell into the patient.The pieces of the metal hook were retrieved and the patient received x-rays that confirmed no further issues.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The assurance clip subject of the reported event is being returned for evaluation.Investigation in progress; a follow-up report will be submitted when additional information becomes available.Udi related data clarification - the manufacturing/expiration date will be included in the follow-up report; therefore, those applicable udi and production identifiers were not included in the initial mdr.

• Brand Name: ASSURANCE
• Common Device Name: 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: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24875516
• Report Number: 1528319-2026-00030
• Device Sequence Number: 15922273
• Product Code: PKL
• UDI-Device Identifier: 00724995219154
• UDI-Public: (01)00724995219154(10)097198
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 04/14/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/14/2026
• 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