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	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up mdr will be filed when additional information is obtained.
Event or Problem Description
The user facility reported that, during withdrawal of an advance capsule endoscope delivery device through the esophagus, the device became stuck in the area of the patient's larynx.The physician succeeded in removing the device and there was no report of patient or user harm.
Additional Manufacturer Narrative
The procedure was completed successfully.However, it was reported that the event resulted in a procedure delay.The lot number of the subject device is unknown.The device subject of this event was returned to us endoscopy for evaluation without the capsule cup portion.Evaluation of the returned portion of the device indicated no damage or malfunction, however a complete investigation could not be performed without the entire device.The reported event is likely attributed to failure by the user to maintain tension on the catheter to keep the capsule cup seated against the endoscope's distal tip during withdrawal, as indicated in the instructions for use.The instructions for use include the following statements: "after capsule delivery, close the finger ring handle until the deployment cable is retracted into the catheter.Maintain tension on the catheter to keep the capsule cup seated against the endoscope's distal tip." us endoscopy has offered in-service training on the use of the device; however, the user facility has declined.No additional issues have been reported.

• 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: 8254741
• Report Number: 1528319-2019-00002
• Device Sequence Number: 1866889
• Product Code: NEZ
• UDI-Device Identifier: 00816765011188
• UDI-Public: (01)00816765011188
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 02/14/2019

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 Model Number: 00711144
• Device Catalogue Number: 00711144
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1