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	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physician chose not to retrieve the capsule cup.Medical imaging was carried out which confirmed that the video capsule remained seated within the capsule cup as it progressed normally through the colon.At the time of use, the subject device was approximately 21 months past the labeled use by date.The use by date was june 30th, 2017.The subject device was returned to us endoscopy for evaluation without the capsule cup component.Evaluation of the returned portion found the threaded barb to which the capsule cup attaches to be functional, and a capsule was successfully deployed using a replacement capsule cup.There have been no other complaints associated with this device lot.Us endoscopy has advised the user facility that the device was beyond its use by date, and the user facility has accepted an offer of in-service training.Training is scheduled to be completed on 4/29/2019.No additional issues have been reported.
Event or Problem Description
The user facility reported that the capsule cup portion of an advance capsule delivery device detached from the device during video capsule deployment.The capsule cup remained attached to the video capsule and was allowed to pass naturally.The procedure was completed and there was no reported harm to the patient.
Additional Manufacturer Narrative
Us endoscopy provided in-service training to the user facility on 4/29/2019.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: 8552118
• Report Number: 1528319-2019-00019
• Device Sequence Number: 2350048
• 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): 05/24/2019

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: 06/30/2017
• Device Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: 1412244
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1