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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 Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73e1900346 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 after several ligations during an operation a clip fell at loading.Therefore, another device of the same lot was used however, the same issue occurred.Then the operation was completed with no problem by using the other device.All the fallen clips were retrieved so that no clip remained in the patient and there was no injury to the patient reported.
 
Event Description
It was reported that after several ligations during an operation a clip fell at loading.Therefore, another device of the same lot was used however, the same issue occurred.Then the operation was completed with no problem by using the other device.All the fallen clips were retrieved so that no clip remained in the patient and there was no injury to the patient reported.
 
Manufacturer Narrative
Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73e1900346 was manufactured on 05/13/2019 a total of (b)(4) pieces.Lot was released on 05/23/2019.Dhr investigation did not show issues related to complaint.The customer returned two units ae05ml autoend05 ml for investigation.The actual sample and a representative sample were returned.The returned samples were visually examined with and without magnification.Visual examination of the actual sample revealed that the sample was returned with the indicator clip in the jaws indicating that there were no clips remaining.The sample appears used as there is biological material present on the device.The representative sample appears typical.Reference file anp1900073869 for investigation photos.First, the indicator clip was removed from the jaws.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 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.Next, the representative sample was tested.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 of the device and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the remaining clips.There were no functional issues found with the returned representative sample.Reference file anp1900073869 for investigation photos.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.The device history record review showed no evidence to suggest a manufacturing related cause.The reported complaint of "clip fell from applier" was not confirmed based upon the sample received.The actual sample and a representative sample were returned.The actual sample 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 autoendo5 with no evidence to suggest a manufacturing related cause.Since there were no clips remaining in the returned complaint sample, the reported complaint issue could not be confirmed , and a probable cause could not be determined.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9481590
MDR Text Key173224882
Report Number3003898360-2019-01495
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 12/03/2019
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 Date05/12/2022
Device Catalogue NumberAE05ML
Device Lot Number73E1900346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received02/11/2020
Supplement Dates FDA Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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