MAUDE Adverse Event Report: US ENDOSCOPY ADVANCE; DELIVERY DEVICE

Model Number	00711144
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices subject of the reported event were not returned to steris for evaluation as the user facility had discarded the devices.Without the return and evaluation of the devices, the cause of the event could not be determined.The advance delivery device ifu states, "open and inspect the device for shipping or handling damage.If damage is evident (e.G.Bends, kinks, cracks, misshaped cup), do not use this device and contact your local product specialist.This device is compatible with an endoscope that has an accessory channel of 2.8mm or greater.Prior to clinical use, you should familiarize yourself with the advance® capsule endoscope delivery device.Open the larger poly bag, remove the paper tape restraint from the coiled device, and gently uncoil the catheter assembly.Remove the small capsule cup bag by sliding it over the end of the catheter.Hold the proximal end in one hand and the distal sheath in the opposite hand and drape in a "u" shape.Open and close the finger rings on the handle two (2) times to make sure it moves smoothly." steris has offered in-service training on the proper use and operation of the advance delivery device and is awaiting a response from the user facility.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that two of their advance delivery devices did not deploy.It is unknown if the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris account manager offered in-service training on the proper use and operation of the advance delivery device; however, the user facility declined.No additional issues have been reported.

• Brand Name: ADVANCE
• Common Device Name: DELIVERY DEVICE
• 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 ; 4403586251
• MDR Report Key: 23729115
• Report Number: 1528319-2025-00112
• Device Sequence Number: 16110070
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)250605(17)280605(10)12435024
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: (10)12435024
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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