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

Catalog Number AE05ML

Device Problems Misfire (2532); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the device would not fire properly or came out closed and would not open.

Event Description

It was reported that the device would not fire properly or came out closed and would not open.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot#: 73e1900524 was manufactured on 05/21/2019 a total of (b)(4) pieces.Lot was released on 05/29/2019.Dhr investigation did not show issues related to complaint.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 protruding from the channel.The sample appears used as there is biological material present on the device.Reference file: (b)(4) for investigation photos.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 first clip became stuck in the bent rotation tab.The clip was manually removed, but the next clip shot out of the channel.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.The sample was received with 11 clips remaining in the channel, indicating that 4 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 became out of position.A capa has been opened to further investigate this issue.Reference file: (b)(4) 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 reported complaint of "misfire" was confirmed based upon the sample received.One device was returned with the rotation tab bent and the first clip protruding from the channel.Upon functional inspection, the first clip became stuck in the bent rotation tab.The sample was disassembled and it was found that the clips were out of position and stacking on one another.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: 9496490
• MDR Text Key: 173230828
• Report Number: 3003898360-2019-01576
• 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,u
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: 05/20/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1