MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE

Model Number	00711144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the return of the full device, the exact cause of the reported event cannot be determined.The instructions for use contains the following instructions, 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 user facility declined steris' offer of in-service training.The device review history (dhr) for the subject lot was reviewed, and no abnormalities were found, and no other complaints associated with the subject lot.This is considered an isolated event.
Event or Problem Description
The user facility reported that the capsule cup of their advance capsule endoscope delivery device broke off and fell into a patient.The piece was retrieved successfully with a snare, and the procedure was completed.No report of injury.

• Brand Name: ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE
• Common Device Name: CAPSULE ENDOSCOPE DELIVERY DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19459954
• Report Number: 1528319-2024-00044
• Device Sequence Number: 17807717
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: 00724995183608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 8639865
• 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: 05/06/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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