MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; INTRODUCER

Model Number S17-45

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2016

Event Type  malfunction  

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 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.

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
• Type of Device: INTRODUCER
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6081523
• MDR Text Key: 59335690
• Report Number: 2031527-2016-00525
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)190705
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1