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

Model Number	00711144
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a patient procedure while using their advance capsule endoscope delivery device, the wire that deploys the pill cam became stuck between the slots of the capsule cup preventing the camera from deploying.No report of injury.
Additional Manufacturer Narrative
The advance endoscope delivery device will be returned to steris for further evaluation.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris endoscopy for evaluation.Steris inspected the advance capsule endoscope delivery device and found the device to be operating properly.No issues were noted with the function or operation of the device; steris was unable to duplicate the reported event.The instructions for use (ifu 731119) 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.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." the device history record was reviewed and confirmed the device was manufactured to specification; no abnormalities were noted.A complaint review was performed and confirmed this event to be isolated for the lot subject of the reported event.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 OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20474692
• Report Number: 1528319-2024-00090
• Device Sequence Number: 12569780
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)240213(17)270213(10)8482771
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/17/2024

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)8482771
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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