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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 Problems Break (1069); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73b1900055 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 while using the applier , the user faced an issue with it.The clips were stuck in the applier; difficult to get out of the applier and one clip came out broken from the applier.So, we could not use this applier.Another device was used.
 
Event Description
It was reported that while using the applier , the user faced an issue with it.The clips were stuck in the applier; difficult to get out of the applier and one clip came out broken from the applier.So, we could not use this applier.Another device was used.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample is for the following tcs: (b)(6) & 1(b)(6).The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent.The sample appears used as there is biological material present on the device.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.The first clip was able to load properly into the jaws and was successfully applied to over-stressed surgical tubing.On the next attempt, no clip fired.Another attempt was made , and the next clip was able to load properly into the jaws and was successfully applied to over-stressed surgical tubing.The sample was disassembled to inspect the internal components.No further damages were observed.The sample was received with 3 clips remaining in the channel, indicating that 12 clips were fired by the end user.The bent rotation tab and dry fire are both indications 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.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 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 "clip broken" was not confirmed based upon the sample received.One sample was returned with the rotation tab bent.Upon functional inspection, two clips were able to load properly into the jaws and were successfully applied to over-stressed surgical tubing.However, a dry fire occurred on the second attempt.The bent rotation tab and dry fire are both indications 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.The clip stacking can also cause the clips to break in the channel.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.
 
Manufacturer Narrative
(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4).Is being reported as a malfunction.There was no serious injury.
 
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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 Key8956355
MDR Text Key156306530
Report Number3003898360-2019-01061
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,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2022
Device Catalogue NumberAE05ML
Device Lot Number73B1900055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2019
Date Manufacturer Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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