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

Catalog Number AE05ML

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73k180013 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 first 3 clips fired ok and then the surgeon noticed piece of metal protruding from the tip.

Event Description

It was reported that the first 3 clips fired ok and then the surgeon noticed piece of metal protuding from the tip.

Manufacturer Narrative

(b)(6).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 the rotation tab bent.The first clip was protruding , and the next clip was out of position in the channel.The sample appears used as there is biological material present on the device.Reference file anp1900075354 for investigation photos.First, the protruding clip was removed , and the trigger cycle was completed.Functional inspection was then 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.No clip fired on the first attempt.However, a clip was protruding from the channel after the trigger cycle was completed.The following clip was out of position.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.A clip with a broken hook was found in the channel.The sample was received with 6 clips remaining including the first clip that was protruding, indicating that 9 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.The clip stacking can also cause the clips to break in the channel, as observed with this sample.It could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.Reference file anp1900075354 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." the clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.The reported complaint of "metal piece protruding from tip" was confirmed based upon the sample received.One device was returned with the rotation tab bent.The first clip was protruding , and the next clip was out of position in the channel.Upon functional inspection, no clip fired on the first attempt.However, a clip was protruding from the channel after the trigger cycle was completed.The following clip was out of position.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.A clip with a broken hook was found in the channel.The clip stacking prevented the clips from loading properly into the jaws.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 capa has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9717136
• MDR Text Key: 180149272
• Report Number: 3003898360-2020-00218
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AE05ML
• Device Lot Number: TBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1