MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT G-JET; LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE

Catalog Number	GJ-1412-22
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978); Physical Property Issue (3008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to report # (b)(4).Analysis of the returned device consisted of a visual and functional evaluation, as well as a device history review.The examination determined that the reported incident is an isolated event and is not believed to have resulted from a manufacturing defect.We have assigned complaint number (b)(4) to this report.(b)(4).
Event or Problem Description
As reported: during tube feeding through gj tube, the hardened disc on top of the silicone pot on the j-side disconnected and prevented the use of this port from feeding tube connection.Patient was taken to the operating room for removal of gj tube and reinsertion of a new gj tube.

• Brand Name: AMT G-JET
• Common Device Name: LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING DEVICE
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 6639596
• Report Number: 1526012-2017-00006
• Device Sequence Number: 10928418
• Product Code: KNT
• UDI-Device Identifier: 00842071101442
• UDI-Public: (01)00842071101442(17)191101(10)161205-208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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?: No
• Operator of Device: No Information
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: GJ-1412-22
• Device Lot Number: 161205-208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1