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

Catalog Number AE05ML

Device Problems Unintended Ejection (1234); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml, lot# 73k1800339 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 applier is not working properly, the clips close by themselves so they fell from the applier.Another applier was used.

Event Description

It was reported that the applier is not working properly, the clips close by themselves so they fell from the applier.Another applier was used.

Manufacturer Narrative

(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 the rotation tab bent.The sample appears used as there is biological material present on the device.First, the trigger cycle was completed.It was observed that the first clip was protruding from the channel.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.The first clip was unable to load properly , and the next clip became stuck in the bent rotation tab causing the tab to bend even more.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.The sample was received with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A capa 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 "clips not holding on the applier" was confirmed based upon the sample received.One device was returned with its trigger partially engaged and the rotation tab bent.After the trigger cycle was completed, the first clip was protruding from the channel.Upon functional inspection, the first clip was unable to load properly , and the next clip became stuck in the bent rotation tab causing the tab to bend even more.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.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 came 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; research triangle park NC
• MDR Report Key: 8587032
• MDR Text Key: 144298564
• Report Number: 3003898360-2019-00504
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73K1800339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1