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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 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73f1900183 investigation did not show issues related to the complaint.The device has not been returned for investigation.
 
Event Description
It was reported that the user ligated properly until the third clip.However, the 4th clip was not loaded properly.Therefore, the device was replaced with the with other company's applier to complete the operation.No clip fell/remained in the patient.
 
Manufacturer Narrative
Qn# (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 had a partially engaged trigger.The sample was returned with its rotation tab bent.The indicator clip was loaded into the jaws of the device, indicating that no more clips were remaining.Although no clips were remaining, functional inspection was performed on the device.The indicator clip was manually removed from the jaws.The sample was able to complete the trigger cycle.Upon the next engagement of the trigger, an audible ratchet sound could be heard indicating that the ratchet ears are intact.The sample was disassembled to inspect the internal components.Upon disassembly, no further damages were found.The bent rotation tab is an indication that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 0 clips remaining indicating that all 15 clips were fired by the end user.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." although the root cause of this complaint issue could not be determined, a capa has been opened to further investigate the clip stacking issue.The reported complaint of "clip(s) not loading properly" was confirmed based upon the sample received.The device was returned with its rotation tab bent and 0 clips remaining in the channel indicating that 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 which could prevent the clips from loading properly into the jaws of the device.Although the reported complaint issue was confirmed, 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 the user ligated properly until the third clip.However, the 4th clip was not loaded properly.Therefore, the device was replaced with the with other company's applier 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 Key10505126
MDR Text Key206106392
Report Number3003898360-2020-00715
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/04/2022
Device Catalogue NumberAE05ML
Device Lot Number73F1900183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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