MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; INTRODUCER

Model Number	S17-45
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device has not been received.
Event or Problem Description
An introducer device inspected by the customer was discovered to have the incorrect label on the packaging.The lot/ serial number from the device in the package did not match the lot/ serial number on the outside of the package.There was no impact to the patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the sample evaluation was able to confirm the reported event.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The root cause of the reported event was identified as a labeling deficiency.Further internal investigation has been carried out and corrective actions to prevent a reoccurrence have been taken.

• Brand Name: AFX
• Common Device Name: INTRODUCER
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6081523
• Report Number: 2031527-2016-00525
• Device Sequence Number: 391422
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)190705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• 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): 10/07/2016

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: 07/05/2019
• Device Model Number: S17-45
• Device Lot Number: 1517080-022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1