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	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to steris endoscopy for evaluation and found damage to the drive cable and the catheter.The bending and kinks observed to the drive cable and catheter indicates the device was positioned in extreme angulation during deployment.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.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." steris endoscopy has provided the user facility with in-service training, which included instruction on device positioning during deployment.No further issues have been reported.
Event or Problem Description
The user facility reported that that during a procedure which included use of the advance capsule delivery device, the device failed to deploy the video capsule and the device deployment cable was observed protruding from a slot in the side of the capsule holder.The deployment cable was retracted into the capsule holder and the device was removed with no report of harm to the patient or user.The video endoscopy was completed without use of the advance device.

• Brand Name: ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE
• Common Device Name: DELIVERY DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• MDR Report Key: 9596156
• Report Number: 1528319-2020-00003
• Device Sequence Number: 13541966
• Product Code: NEZ
• UDI-Device Identifier: 00816765011188
• UDI-Public: (01)00816765011188
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/16/2020

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: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: 19352587
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1