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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73e1900683 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 did not come out to the jaws properly at loading during an operation.Therefore, the user used an endo applier (catalog#: 544965) in place of the auto endo to complete the operation.No clip fell/remained in the patient.
 
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 with the rotation tab bent.A clip was partially loaded incorrectly into the jaws.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.First, the partially loaded clip was manually 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.The next clip was able to load properly and was successfully applied onto over-stressed surgical tubing.This was repeated with the same result for the remaining clips.The sample was disassembled to inspect the internal components.The yoke was broken at the pin position.The sample was received with 6 clips remaining including the partially loaded clip, indicating that 9 clips were fired by the end user.The bent rotation tab and the damage to the yoke are indications that the clips were out of position and stacking on one another in the channel.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 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 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 "clip not loaded properly" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A clip was partially loaded incorrectly.Upon functional inspection, the remaining clips fired properly.The sample was disassembled , and the yoke was broken at the pin position.Although the remaining clips fired properly, the bent rotation tab and the damage to the yoke are indications that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent 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.
 
Event Description
It was reported that a clip did not come out to the jaws properly at loading during an operation.Therefore, the user used an endo applier (catalog#: 544965) in place of the auto endo to complete the operation.No clip fell/remained in the patient.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9716663
MDR Text Key180132576
Report Number3003898360-2020-00206
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2022
Device Catalogue NumberAE05ML
Device Lot Number73E1900683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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