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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 Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73f1800733 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 clips were not loaded into the jaws of the applier properly, and some of them fell from the applier.All clips that fell from the applier were retrieved.There was no patient injury.
 
Event Description
It was reported that clips were not loaded into the jaws of the applier properly, and some of them fell from the applier.All clips that fell from the applier were retrieved.There was no patient injury.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one cartridge 544243 hemolok l clips 3/cart 42/box for investigation.The cartridge was visually examined with and without magnification.Visual examination of the cartridge revealed that it was returned with a closed clip and two intact clips remaining in it.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 no clip in the first position of the channel.The sample appears used as there is biological material present on the device.The sample was returned with two closed clips.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.This was repeated several times with the same result.After several attempts, the indicator clip fired.The device was returned with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The sample was disassembled to inspect the internal components.No defects or damages were observed.Although no clips were returned, there was a significant gap between the last clip in the channel and the indicator clip.This is an indication that the clips were out of position and stacking on one another.Additionally, the customer complained that the clips were not loading properly and were falling out of the applier.The clip stacking could prevent the clips from loading properly into the jaws of the applier.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking 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." the clip stacking could prevent the clips from properly loading into the jaws.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking issue.The reported complaint of "clips not loading properly" was confirmed based upon the sample received.One device was returned with no clip in the first position of the channel.Upon functional inspection, no clip fired.After several attempts, the indicator clip fired.The device was returned with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.Although no clips were returned, there was a significant gap between the last clip in the channel and the indicator clip.This is an indication that the clips were out of position and stacking on one another.Additionally, the customer complained that the clips were not loading properly and were falling out of the applier.The clip stacking could prevent the clips from loading properly into the jaws of the applier.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking issue.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8591299
MDR Text Key144432455
Report Number3003898360-2019-00486
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 company representative,foreig
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/25/2021
Device Catalogue NumberAE05ML
Device Lot Number73F1800733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Date Manufacturer Received06/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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