MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. Assurance; Clip

Model Number	00711884
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure following the deployment of their assurance clip, a metal piece from the device ¿fell off into the colon¿.The piece was retrieved and the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Following the reported event, user facility personnel discarded the assurance clip, and it is not available for return or evaluation.Without the return or evaluation of the device, a cause of the reported event could not be determined.Steris offered in-service training on the proper use and operation for the assurance clip however, the user facility declined.The instructions for use states "the device is suitable for endoscopes with a minimum channel diameter of 2.8mm.If the device is used in a non-forward viewing endoscope, the device may malfunction, or it may not be possible to detach the clip from the catheter.The passage of the clip through a retroflexed or tortuous path may result in the clip separating from the device system and potentially kinking or damaging the device.If the delivery system or clip part kinks or becomes damaged during device insertion or passage, do not use it." no additional issues have been reported.

• Brand Name: Assurance
• Common Device Name: Clip
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50895595
• Report Number: 1528319-2026-00110
• Device Sequence Number: 10705655
• Product Code: PKL
• UDI-Device Identifier: 00724995215804
• UDI-Public: (01)00724995215804(11)260226(17)290225(10)109939
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/25/2026

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: 00711884
• Device Catalogue Number: 00711884
• Device Lot Number: (10)109939
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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