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

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73d1900535 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 there was a loading issue when clip is locked.

Event Description

It was reported that there was a loading issue when clip is locked.

Manufacturer Narrative

(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without mag nification.Visual examination of the returned device revealed that the sample was returned with the rotation tab bent and the first clip out of position in the channel.The centering tab at the distal end of the channel was bent.The corners of the centering tab were not formed correctly.The sample appears used as there is biological material present on the device.Reference file anp1900075412 for investigation photos.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." it could not be determined exactly how or what caused the centering tab to bend.However, the corners of the centering tab were not formed correctly.It is possible that the malformed corners of the centering tab contributed to the bending of the centering tab.The channel is a purchased part from a supplier.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.It could not be determined exactly how or what caused the centering tab to bend.However, the corners of the centering tab were not formed correctly.It is possible that the malformed corners of the centering tab contributed to the bending of the centering tab.The channel is a purchased part from a supplier.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9723045
• MDR Text Key: 180152465
• Report Number: 3003898360-2020-00224
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1900535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1