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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 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73e1900520 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 about the fifth clips and after did not come out to the jaws properly at loading during an operation.Therefore, the device was replaced with a new one.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 mag nification.Visual examination of the returned device revealed that the sample was returned with the rotation tab bent and no clip in the first position of the channel.Reference file anp1900074773 for investigation photos.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.This was repeated several times with the same result.The sample was disassembled to inspect the internal components.No other defects or 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 bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.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 anp1900074773 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 "clips not loaded properly" was confirmed based upon the sample received.One device was returned with the rotation tab bent.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The sample was disassembled and no other defects or damages were observed.The bent rotation tab is an indication that the clips were out of position and stacking on one another 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.
 
Event Description
It was reported that about the fifth clips and after did not come out to the jaws properly at loading during an operation.Therefore, the device was replaced with a new one.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 Key9633697
MDR Text Key176973772
Report Number3003898360-2020-00154
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,u
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2022
Device Catalogue NumberAE05ML
Device Lot Number73E1900520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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