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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 Failure to Advance (2524); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73l1800729 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 during laparoscopic cholecystectomy, a clip fell at loading.Then, another clip got stuck in the applier and the rotation tab was deformed.Therefore, the device was replaced with a new one to complete the operation.The fallen clip was retrieved, and the deformed rotation tab did not touch the patient body.
 
Event Description
It was reported that during laparoscopic cholecystectomy, a clip fell at loading.Then, another clip got stuck in the applier and the rotation tab was deformed.Therefore, the device was replaced with a new one to complete the operation.The fallen clip was retrieved, and the deformed rotation tab did not touch the patient body.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample is for (b)(4).The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with the rotation tab bent and no clip in the first position of the channel.The sample appears used as there is biological material present on the device.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 on the first attempt.The next clip was unable to load properly as it became stuck in the bent rotation tab.The following clip was out of position in the channel.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The sample was received with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.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 "clip fell from applier" was confirmed based upon the sample received.One device was returned with the rotation tab bent and no clip in the first position of the channel.Upon functional inspection, no clip fired on the first attempt.The next clip was unable to load properly as it became stuck in the bent rotation tab.The following clip was out of position in the channel.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.The clip stacking prevented the clips from loading properly into the jaws.Although the reported complaint issue was confirmed based on functional testing, 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.
 
Manufacturer Narrative
(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction complaint number (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 Key8900906
MDR Text Key154541189
Report Number3003898360-2019-00985
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 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/25/2021
Device Catalogue NumberAE05ML
Device Lot Number73L1800729
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Initial Date Manufacturer Received 07/23/2019
Initial Date FDA Received08/16/2019
Supplement Dates Manufacturer Received09/09/2019
09/09/2019
Supplement Dates FDA Received09/13/2019
11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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