MAUDE Adverse Event Report: US ENDOSCOPY ADVANCE; DELIVERY DEVICE

Model Number	00711144
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a patient procedure their advance delivery device did not deploy.The procedure was completed successfully following a short delay.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, an exact cause of the reported event cannot be determined.The advance capsule endoscope 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 2.8 mm or greater.Prior to clinical use, you should familiarize yourself with the advance capsule endoscope delivery device." steris offered in-service training on the proper use and operation of the advance capsule endoscope delivery device; however, the user facility declined.There have been no other similar complaints for this lot.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 ; 4405197842
• MDR Report Key: 22750988
• Report Number: 1528319-2025-00082
• Device Sequence Number: 9363894
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)250226(17)280226(10)12009840
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 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: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: (10)12009840
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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