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)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history record found no issues during manufacture; the device was manufactured to specification.The subject device was not returned to us endoscopy.The instructions for use contain the following: "seat the capsule cup against the endoscope's distal tip by pulling the proximal end of the catheter.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.(note: 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; repeat deployment." in-service training has been offered.
Event or Problem Description
The disposable advance® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of capsules (with the dimensions of 10.5 mm - 11.5 mm in diameter and 23.5 mm - 26.5 mm in length), to the stomach or duodenum.This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.The user facility reported during a procedure the advance capsule endoscope delivery device did not fully deploy the capsule.While removing the device, the capsule separated in the patient's mouth.The capsule was retrieved digitally without issue.There was no report of harm to the patient or user.
Additional Manufacturer Narrative
Follow-up #1: in-service training has been provided to the user facility.Following the training, the sales representative observed a procedure which included successful use of the advance capsule endoscope delivery device.There have been no reports of additional issues.

• 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: 7165641
• Report Number: 1528319-2018-00002
• Device Sequence Number: 1043199
• Product Code: NEZ
• UDI-Device Identifier: 00816765011188
• UDI-Public: (01)00816765011188(17)201009(11)171010(10)1716279
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/09/2020
• Device Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: 1716279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention