MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problems Difficult to Open or Close (2921); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73a1900239 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the surgeon has been using device in the past and without complaint.However, during the recent usage he experienced 2 failed devices consecutively in a row with ae05 which both were unable to clip on and some of the clips tend to drop off before fired.After which, medquest has informed the clinic with regards to the product recall event.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9317850
• MDR Text Key: 170073932
• Report Number: 3003898360-2019-01332
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73A1900239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1