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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
Model Number IPN010797
Device Problem Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73f1900481 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 3 clips were fired properly.Then the applier fired the clips where there was no action to fire clips.Clinical consequences: it was not possible to close vessel with this applier.Another applier was used to solve the issue.
 
Manufacturer Narrative
(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 its trigger partially engaged and no clip in the first position of the channel.The sample appears used as there is biological material present on the device.First, the trigger cycle was completed.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.The sample was disassembled to inspect the internal components.No damages were observed.The device was returned with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.Since no clips were returned, the reported complaint issue could not be confirmed , and a root cause could not be determined.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." a corrective action is not required at this time as it could not be determined what caused the complaint issue since no clips were remaining in the returned sample.Teleflex will continue to monitor and trend on complaints of this nature.The reported complaint of "applier misfired" was not confirmed based upon the sample received.One device was returned.The device was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.A device history record review was performed on the autoend05 with no evidence to suggest a manufacturing related cause.Since there were no clips remaining in the returned device, the reported complaint issue could not be confirmed , and a probable cause could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported that 3 clips were fired properly.Then the applier fired the clips where there was no action to fire clips.Clinical consequences: it was not possible to close vessel with this applier.Another applier was used to solve the issue.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9977539
MDR Text Key188384969
Report Number3003898360-2020-00365
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 03/27/2020
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 Date06/17/2022
Device Model NumberIPN010797
Device Catalogue NumberAE05ML
Device Lot Number73F1900481
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Initial Date Manufacturer Received 03/27/2020
Initial Date FDA Received04/20/2020
Supplement Dates Manufacturer Received05/05/2020
Supplement Dates FDA Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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