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

Model Number	00711144
Medical Device Problem Codes	Difficult to Remove (1528); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via vigilance report that during a patient procedure the capsule cup that deploys the camera from the advance endoscope delivery device broke in half and had to be retrieved from the patient.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.Upon the return of the device, it was noted that the clear portion of the capsule cup was not returned.Without the return of the full device a complete evaluation could not be conducted, and a cause of the reported event could not be determined.The instructions for use 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.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.Pass the catheter through the endoscope's accessory channel using short strokes (1" -1.5" length is recommended to avoid sheath kinking).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.Hold the finger ring handle in a closed position.Push the video capsule into the capsule cup with the optical dome of the video capsule facing out.Listen for an audible click (this indicates that the capsule is appropriately seated within the capsule cup).Deploy the capsule by following these steps: open the finger ring handle briskly until it stops.Confirm capsule delivery endoscopically by looking through the clear capsule cup and seeing the cable and the empty capsule cup.Advancing the capsule cup from the distal tip of the endoscope may enhance the luminal field of view.If the capsule does not fully deploy: close the finger ring handle.Slightly alter the position/angulation of the endoscope.Straighten the handle and catheter and repeat deployment steps.After capsule delivery, close the finger ring handle until the deployment cable is retracted into the catheter." steris offered in-service training on the proper use and operation of the advance delivery device; however, the user facility declined.The device history record for the lot subject of the reported event was reviewed and confirmed the product was manufactured to specifications; no abnormalities were noted.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: 22411684
• Report Number: 1528319-2025-00002
• Device Sequence Number: 20897211
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)240314(17)270314(10)8849913
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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)8849913
• 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: 12/23/2024
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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