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

Catalog Number AE05ML

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73d1900713 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 surgeon has been a seasoned user and made a complaint before.On the incident date the device was jammed and could not fire the clips despite several attempts.The surgeon was upset and gave up and seeking investigation and replacement of this faulty ae05 device he bought for his clinic.The doctor wants to know why this is still happening after last voluntary recall by teleflex.Is this a continuous issue for the product as he has bought considerable quantity and he is concern about this? he returned the faulty piece for investigation and wants the report.

Manufacturer Narrative

Qn#(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 its rotation tab bent and its jaws partially closed.The sample appears used as there is biological material present on the device.Reference file anp1900074080 for i nvestigation 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.No clip fired on the first attempt.Multiple attempts were made and no clips fired.The sample was disassembled to inspect the internal components.No further damages were observed.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The jaws were partially closed due to the jaw opening gizmo (jog) not being engaged to the feeder which occurred since no clips were remaining to support the feeder.The bent rotation tab indicates that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent the clips from properly loading into the jaws.A capa 40010983 has been opened to further investigate this issue.Reference file anp1900074080 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 could prevent 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 the clip stacking issue.The reported complaint of "clips jamming" was not confirmed based upon the sample received.One device was returned.The device was received with 0 clips remaining in the channel indicating that all (b)(4) clips were fired by the end user.Since no clips were returned, it could not be confirmed that the clips were jamming.However, the sample was returned with its rotation tab bent which indicates that the clips were out of position and stacking on one another which could prevent the clips from loading properly into the jaws of the device.Although the reported complaint issue was not confirmed based on the received sample, a defect was confirmed.It could not be determined exactly how or when the clips became out of position, but a capa has been opened to further investigate this issue.

Event Description

It was reported that the surgeon has been a seasoned user and made a complaint before.On the incident date the device was jammed and could not fire the clips despite several attempts.The surgeon was upset and gave up and seeking investigation and replacement of this faulty ae05 device he bought for his clinic.The doctor wants to know why this is still happening after last voluntary recall by teleflex.Is this a continuous issue for the product as he has bought considerable quantity and he is concern about this? he returned the faulty piece for investigation and wants the report.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9491306
• MDR Text Key: 173228572
• Report Number: 3003898360-2019-01571
• 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: 12/09/2019

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: 04/29/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1900713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1