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

Catalog Number AE05ML

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product auto endo5 ml lot# 73e1800769 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 a clip was found to be sticking out from the jaws just before use.Therefore, another unit was used instead.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its trigger partially engaged and with a protective plastic tube taped on the distal end of the device tube.The sample was received with the rotation tab bent and a clip partially loaded incorrectly into the jaws of the device.A triple feed was observed where the second clip was on top of the third clip and was stuck in the bent rotation tab right behind the partially loaded clip.The sample appears used as there is biological material present on the device.First, the first two clips were manually removed , and the trigger cycle was completed.It was observed that the third clip was out of position in the channel.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The third clip was unable to properly load into the jaws of the device.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 12 clips remaining in the channel including the partially loaded clip, indicating that 3 clips were fired by the end user.A non-conformance has been opened to further investigate this issue.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." the reported complaint of "clip stuck out from jaws" was confirmed based upon the sample received.One device was returned with 12 clips remaining in the channel including the partially loaded clip, indicating that 3 clips were fired by the end user.The sample was received with the second clip stuck in the bent rotation tab and on top of the third clip.Upon functional inspection, the third clip was unable to load properly.The sample was disassembled , and it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A non-conformance has been opened to further investigate this issue.

Event Description

It was reported that a clip was found to be sticking out from the jaws just before use.Therefore, another unit was used instead.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8275460
• MDR Text Key: 134022366
• Report Number: 3003898360-2019-00066
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1800769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1