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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 Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device history review for the product auto endo5 ml lot #73l1800543 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 15 clips were not used, clips did not come out from applier.The clip stuck in applier or indicator of orange was missed.The unit was replaced with a new one to complete the operation.No clip fell in the patient.
 
Event Description
It was reported that 15 clips were not used, clips did not come out from applier.The clip stuck in applier or indicator of orange was missed.The unit was replaced with a new one to complete the operation.No clip fell 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 was returned with no clip in the first position of the channel.The returned 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.No clip fired on the first attempt.This was repeated with the same result.On the third attempt, a clip was unable to load properly.There was no clip in the next position of the channel.Another attempt to fire was made, and no clip fired.This was repeated six more times with the same result.The sample was disassembled to inspect the internal components.The proximal end of the feeder was bent.One of the feeder tabs was also not shaped correctly as it was completely horizontal instead of being bent down.The sample was received with 1 clip remaining in the channel indicating that 14 clips were fired by the end user.The clips missing from the first position in the channel, the mis-formed feeder tab and the proximal end of the feeder being bent are indications 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 of the applier.It could not be determined exactly how or when the clips came 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 "clips stuck in applier" 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 on the first attempt.This was repeated with the same result.On the third attempt, a clip was unable to load properly.There was no clip in the next position of the channel.Another attempt to fire was made, and no clip fired.This was repeated six more times with the same result.The sample was disassembled and the proximal end of the feeder was bent.One of the feeder tabs was also not shaped correctly as it was completely horizontal instead of being bent down.The clips missing from the first position in the channel, the mis-formed feeder tab and the proximal end of the feeder being bent are indications 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 of the applier.It could not be determined exactly how or when the clips came out of position.A capa has been opened to further investigate this 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 Key8713706
MDR Text Key148541780
Report Number3003898360-2019-00697
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 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2021
Device Catalogue NumberAE05ML
Device Lot Number73L1800543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/19/2019
Supplement Dates Manufacturer Received07/17/2019
Supplement Dates FDA Received07/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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