MAUDE Adverse Event Report: US ENDOSCOPY ADVANCE; ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE

Model Number	00711144
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their endoscope capsule detached from the advance capsule endoscope delivery device causing the capsule to go down the throat of the patient.The capsule was retrieved, and a second device was used to complete the procedure.No report of injury.
Additional Manufacturer Narrative
The instructions for use contains the following instructions: "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.(moving the finger rings away from the thumb ring is open, moving the finger rings towards the thumb ring is closed).Observe that the deployment cable moves in and out.Note: the finger rings do not advance the full length of the handle shaft.If this unit does not function properly, do not use this product and please contact your local product specialist.Place the scope in a straight position prior to inserting the advance® capsule endoscope delivery device catheter.Hold the finger rings on the advance® device handle in a closed position to ensure that the deployment cable is maintained within the catheter.Pass the catheter through the endoscope's accessory channel using short strokes (1" -1.5" length is recommended to avoid sheath kinking).Observe that the catheter assembly exits the distal end of the endoscope.Remove capsule cup from the small bag.Hold the white portion of the capsule cup between thumb and forefinger, with clear end facing out.Attach the clear end of the capsule cup onto the threaded end of the catheter by turning the capsule cup in a clockwise direction.Tighten capsule cup until it stops and the catheter begins to turn.Pull gently on the capsule cup to confirm proper connection." the device subject of the event was not returned for evaluation.Without the returned device, a root cause could not be determined.Steris offered in-service training on the proper use and operation for the advance capsule endoscope delivery device.The user facility accepted the offer and a follow-up report will be submitted once in-service training has been completed.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Additional Manufacturer Narrative
The user facility changed their mind and elected to decline in-service training.No additional issues have been reported.

• Brand Name: ADVANCE
• Common Device Name: ADVANCE CAPSULE ENDOSCOPE 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: 23555898
• Report Number: 1528319-2025-00104
• Device Sequence Number: 10107593
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/14/2025

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
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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