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

Model Number	00711144
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to use for evaluation.The returned device was evaluated and found to be functional, with no apparent damage to the device.Successful deployment of the video capsule requires brisk manual actuation of the advance device handle.Based on the description of the event and subsequent evaluation, the cause of the unsuccessful deployment and resultant cable extension from the side of the holder was likely to be insufficient handle actuation by the user.The instructions for use include the following statements: "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).To deploy the capsule: 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.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.After capsule delivery, close the finger ring handle until the deployment cable is retracted into the catheter." the device history record of the subject device lot was reviewed and found no noted nonconformities.There have been no other complaints associated with this lot.In-service training was performed and included instruction on handle actuation.No further issues have been reported after in-service was completed.
Event or Problem Description
The user facility reported that during a procedure which included use of the advance capsule delivery device, the device failed to deploy the video capsule.Upon withdrawal of the endoscope and device, the capsule deployment cable was observed extending from the side of capsule holder.The procedure was successfully completed with a second advance device and there was no reported harm to the patient.

• Brand Name: ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE
• Common Device Name: DELIVERY DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8318188
• Report Number: 1528319-2019-00006
• Device Sequence Number: 19396541
• Product Code: NEZ
• UDI-Device Identifier: 00816765011188
• UDI-Public: (01)00816765011188
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K163495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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 Expiration Date: 05/28/2021
• Device Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: 1809098
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1